Shunt, Central Nervous System And Components
FDA product code JXG · Class II (moderate risk) · 21 CFR 882.5550 · Neurology
259510(k) clearances
0PMA approvals
106recalls
Implantimplanted device
Manufacturers
- Codman & Shurtleff, Inc. 23
- Holter-Hausner Intl. 21
- Pudenz-Schulte Medical Research Corp. 18
- Cordis Corp. 18
- Medtronic Neurosurgery 18
- Integra LifeSciences Corp. 14
- Aesculap, Inc. 13
- Phoenix Biomedical Corp. 11
- Radionics, Inc. 10
- Sophysa SA 10
- Integra Neurocare, LLC 9
- Integra Lifesciences Production Corporation 7
- Johnson & Johnson Professionals, Inc. 7
- Integra Neurosciences Implants S.A. 6
- Medos International SARL 4
- Medtronic PS Medical 4
- Baxter Healthcare Corp 4
- Irras USA, Inc. 4
- American Heyer Schulte 4
- Aqueduct Critical Care, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional | Integra Lifesciences Production Corporation | 06/23/2026SE |
| K251598 | IntellidropJXG · Traditional | Brainspace, Inc. | 12/10/2025SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | Sophysa | 11/28/2025SE |
| K252514 | Evac-MriJXG · Traditional | Phasor Health, LLC | 11/05/2025SESD |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional | Integra Lifesciences Production Corporation | 08/08/2025SE |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | Integra Lifesciences Production Corporation | 08/06/2025SE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | Sophysa | 06/20/2025SE |
| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
| K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic)JXG · Traditional | Borvo Medical, Inc. | 08/20/2024SE |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…JXG · Traditional | Integra Lifesciences Production Corporation | 01/17/2024SE |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetJXG · Traditional | Integra Lifesciences Production Corporation | 12/19/2023SE |
| K231664 | IRRAflow Active Fluid Exchange System (AFES)JXG · Traditional | Irras USA, Inc. | 10/19/2023SE |
| K221694 | External Drainage SystemJXG · Traditional | Jmed(Shenzhen) Technology Limited | 02/09/2023SE |
| K222422 | Polaris Valve Electronic Reading InstrumentJXG · Traditional | Sophysa | 02/02/2023SE |
| K223330 | Certas Plus Programmable ValvesJXG · Traditional | Integra Lifesciences Production Corporation | 02/01/2023SE |
| K223603 | Reflow System Mini and ReFlow Mini FlusherJXG · Special | Anuncia Medical, Inc. | 12/29/2022SE |
| K222471 | IRRAflow Active Fluid Exchange System (AFES)JXG · Special | Irras USA | 12/08/2022SE |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesJXG · Traditional | Integra Lifesciences Production Corporation | 10/14/2022SE |
| K221918 | ReFlow System MiniJXG · Traditional | Anuncia Medical, Inc. | 09/29/2022SE |
| K212641 | StrataMR II Valves and ShuntsJXG · Special | Medtronic Neurosurgery | 09/16/2021SE |
| K200950 | Ventricular CatheterJXG · Special | Aesculap, Inc. | 05/08/2020SE |
| K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitJXG · Special | Irras USA, Inc. | 04/29/2020SE |
| K192266 | M. Blue Adjustable Shunt SystemJXG · Traditional | Aesculap, Inc. | 11/21/2019SE |
| K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitJXG · Traditional | Irras USA, Ltd. | 11/15/2019SE |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External…JXG · Traditional | Integra LifeSciences Corporation | 10/11/2019SE |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 ValvesJXG · Traditional | Aesculap, Inc. | 07/05/2019SE |
| K182265 | CodMan Certas Plus Programmable ValveJXG · Traditional | Integra Lifesciences Corp. | 11/20/2018SE |
| K181902 | Codman Certas Plus Electronic Tool KitJXG · Traditional | Integra Lifesciences Corp. | 10/25/2018SE |
| K181622 | StrataMR guider toolJXG · Traditional | Medtronic Neurosurgery | 10/01/2018SE |
| K171880 | IRRAflow CNS SystemJXG · Traditional | Irras, Inc. | 07/13/2018SE |
| K181301 | Smart External Drain (SED) SystemJXG · Special | Aqueduct Critical Care, Inc. | 06/14/2018SE |
| K172035 | EKOS ultrasound EVD Device, EVD Control UnitJXG · Traditional | Btg International, Inc. | 03/24/2018SE |
| K172759 | Smart External Drain (SED) SystemJXG · Traditional | Aqueduct Critical Care, Inc. | 11/14/2017SE |
| K172006 | Alivio Ventricular Catheter and Flusher System (Alivio System)JXG · Traditional | Alcyone Lifesciences, Inc. | 11/09/2017SE |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional | Codman & Shurtleff, Inc. | 10/16/2017SE |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | Codman & Shurtleff, Inc. | 10/03/2017SE |
| K170599 | SureFlo EVD CatheterJXG · Traditional | Arkis Biosciences, Inc. | 08/31/2017SE |
| K171586 | Smart External Drain (SED) SystemJXG · Special | Aqueduct Critical Care, Inc. | 06/30/2017SE |
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…JXG · Traditional | Aesculap, Inc. | 02/27/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | Codman & Shurtleff, Inc. | 10/28/2016SE |
| K161605 | Smart External Drain (SED) SystemJXG · Traditional | Aqueduct Critical Care, Inc. | 10/27/2016SE |
| K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG · Special | Integra LifeSciences Corporation | 09/22/2016SE |
| K152700 | StrataMR Valves and ShuntsJXG · Traditional | Medtronic Neurosurgery | 04/07/2016SE |
| K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to…JXG · Traditional | Integra LifeSciences Corporation | 03/14/2016SE |
| K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel…JXG · Traditional | Integra LifeSciences Corporation | 03/04/2016SE |
| K150898 | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmJXG · Traditional | Moller Medical GmbH | 12/18/2015SE |
| K152152 | Codman Certas Plus Programmable ValveJXG · Traditional | Medos International SARL | 10/27/2015SE |
| K141687 | Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemJXG · Traditional | Aesculap, Inc. | 04/02/2015SE |
| K141227 | Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with SiphonxJXG · Traditional | Sophysa SA | 04/02/2015SE |
| K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll KitJXG · Traditional | Medos International SARL | 02/19/2015SE |
| K140722 | Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve…JXG · Traditional | Integra LifeSciences Corporation | 01/06/2015SE |
| K121248 | Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM)…JXG · Traditional | Moller Medical GmbH | 12/13/2013SE |
| K123554 | ShuntcheckJXG · Traditional | Neurodx Development, LLC | 03/07/2013SE |
| K123524 | Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | Medtronic Neurosurgery | 02/13/2013SE |
| K122118 | Hakim Programmable and Precision Valve Shunt SystemJXG · Special | Codman & Shurtleff, Inc. | 08/03/2012SE |
| K120559 | Aesculap-Meithke Prosa Adjustable Shunt SystemJXG · Traditional | Aesculap, Inc. | 05/24/2012SE |
| K113526 | Codman Certas Programmable Valve SystemJXG · Special | Medos International SARL | 02/16/2012SE |
| K110560 | Medtronic Ares Antibiotic-Impregnated CatheterJXG · Traditional | Medtronic Neurosurgery | 11/18/2011SE |
| K110206 | Aesculap- Meithke Shunt SystemJXG · Traditional | Aesculap, Inc. | 10/27/2011SE |
| K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemJXG · Traditional | Medos International SARL | 10/17/2011SE |
| K101381 | Horizontal-Vertical Lumbar Valve and Spetzler Lumbar Peritoneal Shunt SystemsJXG · Traditional | Integra LifeSciences Corporation | 07/07/2011SE |
| K110751 | Codman Bactiseal Endoscopic Venticular CatheterJXG · Traditional | Codman & Shurtleff, Inc. | 05/09/2011SE |
| K102961 | Holter In-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors…JXG · Special | Codman & Shurtleff, Inc. | 02/18/2011SE |
| K102589 | Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterJXG · Special | Codman & Shurtleff, Inc. | 01/14/2011SE |
| K103003 | Aesculap- Meithke Progav Programmable Shunt SystemJXG · Special | Aesculap, Inc. | 11/09/2010SE |
| K093968 | Osv II Low Flow Low Pro ValveJXG · Special | Integra LifeSciences Corporation | 01/22/2010SE |
| K091328 | Siphonx Gravitational Antisiphon DeviceJXG · Traditional | Sophysa SA | 01/22/2010SE |
| K092395 | Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve SystemJXG · Traditional | Integra Lifesciences Corp. | 11/19/2009SE |
| K091312 | PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | Medtronic Neurosurgery | 09/02/2009SE |
| K090342 | Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400JXG · Traditional | Sophysa SA | 08/11/2009SE |
| K091346 | Codman Hakim Micro II ValveJXG · Special | Codman & Shurtleff, Inc. | 06/02/2009SE |
| K090348 | Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter SetJXG · Special | Codman & Shurtleff, Inc. | 03/04/2009SE |
| K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836JXG · Special | Medtronic Neurosurgery | 11/20/2008SE |
| K081773 | Osv IIJXG · Special | Integra Neurosciences Implants S.A. | 11/06/2008SE |
| K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635JXG · Special | Medtronic Neurosurgery | 08/27/2008SE |
| K081942 | Neurocath AGJXG · Special | Vygon Neuro | 08/12/2008SE |
| K080168 | Shuntcheck - CSF Shunt Flow DetectorJXG · Traditional | Neuro Diagnostic Devices | 05/16/2008SE |
| K073139 | Small Lumen Peritoneal CatheterJXG · Special | Medtronic Neurosurgery | 01/30/2008SE |
| K072929 | Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020…JXG · Special | Integra LifeSciences Corporation | 12/07/2007SE |
| K063836 | Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701…JXG · Traditional | Medtronic Neurosurgery | 08/16/2007SE |
| K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TJXG · Traditional | Aesculap, Inc. | 01/17/2007SE |
| K061876 | Codman VPV System, Model 82-3192JXG · Traditional | Codman & Shurtleff, Inc. | 10/16/2006SE |
| K061568 | Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733…JXG · Special | Codman & Shurtleff, Inc. | 09/29/2006SE |
| K062599 | Monitorr Icp External Drainage and Monitoring SystemsJXG · Special | Integra LifeSciences Corporation | 09/27/2006SE |
| K060681 | Medtronic PS Medical Strata Type ValueJXG · Special | Medtronic Neurosurgery | 09/15/2006SE |
| K053350 | Modification to Codman Hakim Shunt SystemsJXG · Special | Codman & Shurtleff, Inc. | 01/19/2006SE |
| K053107 | Codman Hakim Programmable Valve W/Wo SiphonguardJXG · Special | Codman & Shurtleff, Inc. | 01/19/2006SE |
| K052386 | Medtronic M2 Magnet Adjustment ToolJXG · Traditional | Medtronic Neurosurgery | 12/16/2005SE |
| K050739 | Codman VPV System, Model 82-3192JXG · Traditional | Codman & Shurtleff, Inc. | 07/18/2005SE |
| K041992 | Medtronic StratavariusJXG · Traditional | Medtronic Neurosurgery | 01/28/2005SE |
| K042825 | Accudrain External CSF Drainage SystemJXG · Traditional | Integra LifeSciences Corporation | 12/21/2004SE |
| K042481 | Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400JXG · Traditional | Sophysa SA | 12/14/2004SE |
| K042359 | Subdural Evacuating Port System Cranial Access Kit (Seps-Ca), (Seps-Cal)…JXG · Traditional | Medical Designs, LLC | 11/17/2004SE |
| K040021 | Shuntcheck (Prometheus 1)JXG · Traditional | Samuel Neff M.D. | 11/02/2004SE |
| K042465 | PS Medical Strata II ValveJXG · Special | Medtronic Neurosurgery | 10/19/2004SE |
| K042558 | Equi-Flow Valve and Shunt SystemJXG · Traditional | Integra Neurosciences Implants S.A. | 10/06/2004SE |
| K042198 | PS Medical Neurosurgical ImplantsJXG · Special | Medtronic Neurosurgery | 09/24/2004SE |
| K042192 | Low Flow Osv II Hydrocephalus ValveJXG · Special | Integra Neurosciences Implants S.A. | 09/02/2004SE |
| K040943 | Medtronic PS Medical Strata ValveJXG · Traditional | Medtronic Neurosurgery | 06/15/2004SE |
| K041296 | Modification to Hakim Precision Valve System, Hakim Programmable Valve System, Hakim…JXG · Special | Codman & Shurtleff, Inc. | 06/10/2004SE |
| K033704 | Modification to Lumbo-Peritoneal Shunts and Lumbar Drainage CathetersJXG · Special | Vygon Us, LLC | 05/27/2004SE |
| K033017 | Phoenix Infusion CatheterJXG · Traditional | Phoenix Biomedical | 04/07/2004SE |
| K040201 | Modification to Burr Hole Valve and Shunt SystemJXG · Special | Integra Neurosciences Implants S.A. | 02/26/2004SE |
| K031097 | Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBJXG · Traditional | Sophysa SA | 02/26/2004SE |
| K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideJXG · Special | Medtronic Neurosurgery | 01/13/2004SE |
| K033698 | Contour-Flex Valve and Shunt SystemJXG · Special | Integra Neurosciences Implants S.A. | 12/17/2003SE |
| K030468 | Acura Elite Gravity Compensating ReservoirJXG · Traditional | Phoenix Biomedical Corp. | 10/15/2003SE |
| K032817 | External Drainage SetJXG · Special | Integra Neurosciences Implants S.A. | 10/06/2003SE |
| K030081 | CSF400 and CSF600JXG · Traditional | Inmed Ltda. | 10/06/2003SE |
| K031303 | Aesculap-Miethke Shunt System Gravity Assisted Valve (Gav)JXG · Special | Aesculap, Inc. | 06/04/2003SE |
| K030698 | Aesculap - Miethke Shunt System W/ Nph-DsvJXG · Special | Aesculap, Inc. | 03/20/2003SE |
| K030289 | Hermetic Plus External CSF Drainage Systems, INS-8301,INS-8302,INS-8700, NL850-830NJXG · Special | Integra Lifesciences Corp. | 02/26/2003SE |
| K024101 | Phoenix Universal Shunt SystemJXG · Special | Phoenix Biomedical Corp. | 01/27/2003SE |
| K024040 | Accura Elite Shunt SystemJXG · Special | Phoenix Biomedical Corp. | 01/27/2003SE |
| K022554 | Monitorr Icp External CSF Drainage and Monitoring SystemJXG · Special | Integra Neurosciences | 08/23/2002SE |
| K021644 | Perf (Ommaya Style) ReservoirsJXG · Traditional | Phoenix Biomedical Corp. | 08/06/2002SE |
| K021653 | Codman Bactiseal Evd Catheter SetJXG · Traditional | Codman & Shurtleff, Inc. | 07/29/2002SE |
| K021196 | Neuron Therapeutics, Inc., 14-GAUGE Lumbar Puncture Set, Model PN1000735JXG · Traditional | Neuron Therapeutics, Inc. | 07/01/2002SE |
| K020667 | Codman Hakim Shunt SystemsJXG · Special | Codman & Shurtleff, Inc. | 03/28/2002SE |
| K013488 | Sophy Pressure Adjustable Valve System Model SM8JXG · Traditional | Sophysa SA | 03/27/2002SE |
| K011030 | Aesculap -Miethke Shunt SystemJXG · Traditional | Aesculap, Inc. | 03/01/2002SE |
| K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855JXG · Traditional | Medtronic PS Medical | 02/11/2002SE |
| K003564 | Hakim Programmer and TransmitterJXG · Special | Codman & Shurtleff, Inc. | 12/20/2000SE |
| K002970 | Subdural Evacuating Port System, Model 11-9901JXG · Traditional | Medical Designs, LLC | 12/12/2000SE |
| K002476 | Lumboperitoneal Shunt SystemJXG · Traditional | Phoenix Biomedical Corp. | 11/09/2000SE |
| K992465 | Sophy SU8 Pressure Adjustable ValveJXG · Traditional | Sophysa SA | 09/21/2000SE |
| K991502 | Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022JXG · Traditional | Medtronic PS Medical | 09/12/2000SE |
| K992226 | XDS External CSF Drainage and Monitoring SystemJXG · Traditional | Radionics, Inc. | 08/04/2000SE |
| K000514 | Rumbar Drainage SystemJXG · Traditional | Phoenix Biomedical Corp. | 05/10/2000SE |
| K992173 | Siphonguard CSF Control DeviceJXG · Traditional | Johnson & Johnson Professionals, Inc. | 04/07/2000SE |
| K000057 | Radionics Lumboperitoneal ShuntJXG · Traditional | Radionics, Inc. | 03/20/2000SE |
| K990660 | NMT Neurosciences Control Unit, Model 910-600 & NMT Neurosciences Disposable Drainage…JXG · Traditional | Nmt Neurosciences Implants S.A. | 09/23/1999SE |
| K992379 | Radionics XDC External Ventricular CatheterJXG · Traditional | Radionics, Inc. | 09/08/1999SE |
| K981246 | Beverly Referential Valve (NL850-9710) with Integral Peritoneal Catheter (NL850-9720)…JXG · Traditional | Integra Neurocare, LLC | 05/26/1999SE |
| K991429 | Diamond II ValveJXG · Special | Phoenix Biomedical Corp. | 05/19/1999SE |
| K980903 | Radionics Equi-Flow Valve, Ventricular and Peritoneal Catheter with Ez-CoatJXG · Traditional | Radionics, Inc. | 04/19/1999SE |
| K990256 | CRX World ShuntJXG · Special | Phoenix Biomedical Corp. | 04/01/1999SE |
| K984583 | The Bioplate Shunt ConnectorJXG · Traditional | Biomedics | 03/15/1999SE |
| K984053 | Becker External Drainage and Monitoring SystemJXG · Traditional | Medtronic PS Medical | 02/04/1999SE |
| K974096 | CRX Diamond ValveJXG · Traditional | Phoenix Biomedical Corp. | 12/08/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | Johnson & Johnson Professionals, Inc. | 07/17/1998SE |
| K974739 | Hakim Programmable Valve SystemJXG · Traditional | Johnson & Johnson Professionals, Inc. | 07/01/1998SE |
| K981046 | Medtronic PS Medical External Drainage and Monitoring (Edm) Ventricular Catheter, 20CM…JXG · Traditional | Medtronic PS Medical | 06/16/1998SE |
| K974726 | Subdural Drainage Catheter Kit, Subdural CatheterJXG · Traditional | Elekta Implants, SA | 03/18/1998SE |
| K974708 | Gemini Standard and Mini ValvesJXG · Traditional | Neurocare Group | 03/10/1998SE |
| K971799 | Precision Flow Osv IIJXG · Traditional | Elekta Implants, SA | 02/06/1998SE |
| K973774 | Codman Hakim Micro Precision ValveJXG · Traditional | Johnson & Johnson Professionals, Inc. | 12/29/1997SE |
| K973525 | Maurice Worldwide Shunt SystemJXG · Traditional | Integra Neurocare, LLC | 12/16/1997SE |
| K972994 | External CSF Drainage Management SystemsJXG · Traditional | Integra Neurocare, LLC | 11/03/1997SE |
| K971617 | Endoscopic Ventricular CatheterJXG · Traditional | Integra Neurocare, LLC | 07/31/1997SE |
| K971511 | Radionics Contour Flex Valve, Radionics Contour Flex Plus ValveJXG · Traditional | Radionics, Inc. | 07/24/1997SE |
| K964923 | Codman Lumbar Drainage Catheter KitJXG · Traditional | Johnson & Johnson Professionals, Inc. | 06/25/1997SE |
| K970983 | Peritoneal/Cardiac CatheterJXG · Traditional | Integra Neurocare, LLC | 06/13/1997SE |
| K970578 | Radionics Burr Hole ValveJXG · Traditional | Radionics, Inc. | 06/04/1997SE |
| K970658 | Lumbar Drainage Accessory KitJXG · Traditional | Integra Neurocare, LLC | 05/19/1997SE |
| K964386 | Radionics Contour Flex Plus ValveJXG · Traditional | Radionics, Inc. | 01/31/1997SE |
| K964371 | Shunt Tap with Icp Monitoring Access PortJXG · Traditional | Integra Neurocare, LLC | 01/31/1997SE |
| K955265 | Cordis Sharp-Ended Stylet; Blunt-Ended Stylet; Cyst Puncture CatheterJXG · Traditional | Cordis Corp. | 12/20/1996SE |
| K961859 | Novus Standard and Pediatric ValvesJXG · Traditional | Integra Neurocare, LLC | 12/16/1996SE |
| K963802 | Shunt TapJXG · Traditional | Integra Neurocare, LLC | 12/12/1996SE |
| K960159 | Cordis Straight or Finned Ventr Cath (W/Radio Dots)JXG · Traditional | Cordis Corp. | 10/25/1996SE |
| K962990 | Radionics Siphon Limiting Device (SLD)JXG · Traditional | Radionics, Inc. | 10/23/1996SE |
| K962097 | Ventricular Catheter SetJXG · Traditional | Cook, Inc. | 08/29/1996SE |
| K960435 | Phoenix CRX ValveJXG · Traditional | Phoenix Biomedical Corp. | 08/27/1996SE |
| K955832 | Cordis Ventricular Antechamber (Va)JXG · Traditional | Cordis Corp. | 03/25/1996SE |
| K954285 | Contour Flex Valves (Regular & Small)JXG · Traditional | Radionics, Inc. | 01/26/1996SE |
| K954021 | External Drainage System (Eds and Eds II)JXG · Traditional | Johnson & Johnson Professionals, Inc. | 10/24/1995SE |
| K944595 | Cordis Horizontal-Verical Valve SystemJXG · Traditional | Cordis Corp. | 10/19/1995SE |
| K951258 | PS Medical Bioglide Csf-Flow Control Shunt KitJXG · Traditional | Pudenz-Schulte Medical Research Corp. | 09/18/1995SE |
| K944222 | Codman-Medos Valve Shunt SystemJXG · Traditional | Johnson & Johnson Professionals, Inc. | 07/28/1995SE |
| K932769 | Camino Ventricular Drainage SystemJXG · Traditional | Camino Laboratories, Inc. | 03/30/1995SE |
| K935560 | PMT External External Drainage System (Eds)JXG · Traditional | Pmt Corp. | 11/07/1994SE |
| K932429 | Cordis Gravity Compensating AccessoryJXG · Traditional | Cordis Corp. | 07/20/1994SE |
| K934545 | PS Medical Delta Burr Hole ValveJXG · Traditional | Pudenz-Schulte Medical Research Corp. | 04/28/1994SE |
| K925810 | Cordis Polypropylene Burr Hole ReservoirJXG · Traditional | Cordis Corp. | 03/02/1994SE |
| K931989 | Ventri-CathJXG · Traditional | Gesco Intl., Inc. | 07/21/1993SE |
| K930222 | Camino Ventricular Access DeviceJXG · Traditional | Camino Laboratories, Inc. | 04/15/1993SE |
| K913412 | PS Medical Csf-Access DeviceJXG · Traditional | Pudenz-Schulte Medical Research Corp. | 03/30/1993SE |
| K924600 | Integral Drainage/Ventricular/Lumbar Drainage SetsJXG · Traditional | Cordis Corp. | 12/10/1992SE |
| K921936 | Cordis Polypropylene Straight, T & Y ConnectorJXG · Traditional | Cordis Corp. | 10/30/1992SE |
| K922941 | Clinical Neuro Systems Monitorr Icp Ventricular CaJXG · Traditional | Clinical Neuro Systems, LLC | 08/26/1992SE |
| K922936 | Clinical Neuro Systems Monitorr Icp Lumbar CatheteJXG · Traditional | Clinical Neuro Systems, LLC | 08/26/1992SE |
| K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SyJXG · Traditional | Clinical Neuro Systems, LLC | 03/16/1992SE |
| K914995 | Cordis Straight Ventricular CatheterJXG · Traditional | Cordis Corp. | 03/09/1992SE |
| K913842 | Cordis Right-Angle Catheter GuideJXG · Traditional | Cordis Corp. | 02/19/1992SE |
| K913636 | Orbis-Sigma Valve System for Ventricular ShuntingJXG · Traditional | Cordis Corp. | 12/12/1991SE |
| K911433 | Right-Angle Catheter for Ventricular DrainageJXG · Traditional | Cordis Corp. | 09/16/1991SE |
| K905860 | Heyer-Schulte Spinal Cyst Catheter/ModificationJXG · Traditional | Baxter Healthcare Corp | 09/10/1991SE |
| K910938 | Codman External Drainage System II (Eds II)JXG · Traditional | Codman & Shurtleff, Inc. | 08/16/1991SE |
| K904883 | OptyxJXG · Traditional | Baxter Healthcare Corp | 07/24/1991SE |
| K911410 | PS Medical Button ValveJXG · Traditional | Pudenz-Schulte Medical Research Corp. | 06/28/1991SE |
| K910853 | Graduated Cylinder of External Drainage SetJXG · Traditional | Cordis Corp. | 04/24/1991SE |
| K903844 | Omnishunt System for Ventricular ShuntingJXG · Traditional | Cordis Corp. | 12/28/1990SE |
| K904120 | Accu-Flo* Unitized ShuntJXG · Traditional | Codman & Shurtleff, Inc. | 10/09/1990SE |
| K902783 | PS Medical Delta Csf-Flow Control ValveJXG · Traditional | Pudenz-Schulte Medical Research Corp. | 08/08/1990SE |
| K902257 | Codman* External Drainage System II (Eds-Ii)JXG · Traditional | Codman & Shurtleff, Inc. | 07/19/1990SE |
| K895524 | Hydrocephalus Shunt System, Low/Medium/High Press.JXG · Traditional | Theramed, Inc. | 04/10/1990SE |
| K900676 | Csf-Flow Control Valve, Cylindrical & Shunt KitJXG · Traditional | Pudenz-Schulte Medical Research Corp. | 04/03/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2173-2026 Class II | Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID:…Out-of-specification endotoxin result that did not meet the acceptance criteria. | Integra LifeSciences Corp. (NeuroSciences) | 04/10/2026Open, Classified |
| Z-0979-2025 Class II | CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820.…Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the… | Integra LifeSciences Corp. | 12/16/2024Open, Classified |
| Z-0978-2025 Class II | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL.…Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the… | Integra LifeSciences Corp. | 12/16/2024Open, Classified |
| Z-0977-2025 Class II | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810…Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the… | Integra LifeSciences Corp. | 12/16/2024Open, Classified |
| Z-2138-2024 Class II | CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining…Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise… | Integra LifeSciences Corp. | 05/07/2024Open, Classified |
| Z-2137-2024 Class II | CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the…Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise… | Integra LifeSciences Corp. | 05/07/2024Open, Classified |
| Z-2136-2024 Class II | CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of…Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may… | Integra LifeSciences Corp. | 05/07/2024Open, Classified |
| Z-0635-2024 Class II | EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx onlySterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. | Natus Medical Incorporated | 11/28/2023Open, Classified |
| Z-0634-2024 Class II | External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx onlySterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. | Natus Medical Incorporated | 11/28/2023Open, Classified |
| Z-2412-2023 Class II | Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection…Product labeling contains incorrect expiration date | Medtronic Neurosurgery | 06/28/2023Open, Classified |
| Z-1143-2021 Class II | Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for…The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal… | Natus Manufacturing Limited | 01/12/2021Terminated |
| Z-1117-2021 Class II | Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following…Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and… | Medtronic Neurosurgery | 01/11/2021Open, Classified |
| Z-1116-2021 Class II | Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and…Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and… | Medtronic Neurosurgery | 01/11/2021Open, Classified |
| Z-1115-2021 Class II | Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following…Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and… | Medtronic Neurosurgery | 01/11/2021Open, Classified |
| Z-0873-2021 Class II | REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344…Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design… | Medtronic Neurosurgery | 12/16/2020Open, Classified |
| Z-0872-2021 Class II | REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344…Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design… | Medtronic Neurosurgery | 12/16/2020Open, Classified |
| Z-0871-2021 Class II | REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344…Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design… | Medtronic Neurosurgery | 12/16/2020Open, Classified |
| Z-0725-2021 Class II | Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the…Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as… | Integra LifeSciences Corp. | 12/14/2020Terminated |
| Z-0724-2021 Class II | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the…Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as… | Integra LifeSciences Corp. | 12/14/2020Terminated |
| Z-0740-2021 Class II | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in…There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the… | Medtronic Neurosurgery | 12/08/2020Open, Classified |
| Z-0739-2021 Class II | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in…There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the… | Medtronic Neurosurgery | 12/08/2020Open, Classified |
| Z-0738-2021 Class II | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in…There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the… | Medtronic Neurosurgery | 12/08/2020Open, Classified |
| Z-1312-2019 Class I | LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1…The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and… | Integra LifeSciences Corp. | 04/08/2019Terminated |
| Z-1311-2019 Class I | MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage:…The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and… | Integra LifeSciences Corp. | 04/08/2019Terminated |
| Z-1310-2019 Class I | MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102…The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and… | Integra LifeSciences Corp. | 04/08/2019Terminated |
| Z-0809-2018 Class II | proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt…A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve… | Aesculap Implant Systems LLC | 09/21/2017Terminated |
| Z-1702-2017 Class I | The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous…Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator… | Medtronic Neurosurgery | 02/22/2017Terminated |
| Z-1121-2017 Class II | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All…Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15… | Medtronic Neurosurgery | 01/17/2017Terminated |
| Z-2910-2016 Class II | Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | Integra LifeSciences Corp. | 08/23/2016Terminated |
| Z-2909-2016 Class II | Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | Integra LifeSciences Corp. | 08/23/2016Terminated |
| Z-2908-2016 Class II | Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | Integra LifeSciences Corp. | 08/23/2016Terminated |
| Z-2907-2016 Class II | Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | Integra LifeSciences Corp. | 08/23/2016Terminated |
| Z-2906-2016 Class II | CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | Integra LifeSciences Corp. | 08/23/2016Terminated |
| Z-2905-2016 Class II | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | Integra LifeSciences Corp. | 08/23/2016Terminated |
| Z-1012-2015 Class II | Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended…Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The… | Aesculap, Inc. | 12/17/2014Terminated |
| Z-0814-2015 Class III | Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to…Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients'… | Aesculap, Inc. | 11/11/2014Terminated |
| Z-0502-2015 Class II | The Dual Switch Valve is used for fluid drainage from the ventricles into the…Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect… | Aesculap, Inc. | 10/24/2014Terminated |
| Z-0091-2015 Class II | Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog…tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or… | Codman & Shurtleff, Inc. | 09/15/2014Terminated |
| Z-0090-2015 Class II | Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System)…tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or… | Codman & Shurtleff, Inc. | 09/15/2014Terminated |
| Z-0089-2015 Class II | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System)…tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or… | Codman & Shurtleff, Inc. | 09/15/2014Terminated |
| Z-2191-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-2190-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-2189-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-2188-2014 Class II | Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-2187-2014 Class II | Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-2186-2014 Class II | Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code:…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-2185-2014 Class II | Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-2184-2014 Class II | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | Codman & Shurtleff, Inc. | 07/03/2014Terminated |
| Z-1924-2014 Class I | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites…Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the… | Medtronic Neurosurgery | 06/09/2014Terminated |
| Z-1923-2014 Class I | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites…Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the… | Medtronic Neurosurgery | 06/09/2014Terminated |