Catheter, Continuous Flush
FDA product code KRA · Class II (moderate risk) · 21 CFR 870.1210 · Cardiovascular
176510(k) clearances
0PMA approvals
80recalls
Manufacturers
- Micro Therapeutics, Inc. 17
- Cook, Inc. 14
- Cordis Neurovascular, Inc. 13
- Boston Scientific Corporation 11
- Merit Medical Systems, Inc. 7
- Scimed Life Systems, Inc. 6
- Instylla, Inc. 4
- Edwards Lifesciences, LLC 4
- Mercator Medsystems, Inc. 4
- Medex, Inc. 3
- Target Therapeutics 3
- Baxter Healthcare Corp 3
- Flowmedica, Inc. 3
- Pilling Co. 2
- Parke-Davis Co. 2
- Interventional Innovations Corp. 2
- Veinrx, Inc. 2
- Precision Vascular Systems, Inc. 2
- Terumo Medical Corp. 2
- Bentley Laboratories, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254051 | Extroducer Infusion Catheter SystemKRA · Traditional | SmartWise Sweden AB | 09/11/2026SE |
| K261610 | Verge MicrocatheterKRA · Special | Instylla, Inc. | 06/11/2026SE |
| K260771 | TruSelect 2.6 MicrocatheterKRA · Special | Boston Scientific Corporation | 05/15/2026SE |
| K250794 | InVera Infusion DeviceKRA · Traditional | Invera Medical | 03/12/2026SE |
| K243534 | Micro CatheterKRA · Traditional | Suzhou Zenith Vascular SciTech Limited | 07/30/2025SE |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional | Transit Scientific, LLC | 11/29/2023SE |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional | Ablative Solutions, Inc. | 07/05/2023SE |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mmKRA · Traditional | Vvt Medical , Ltd. | 06/20/2023SE |
| K230957 | TriSalus TriNav® LV Infusion SystemKRA · Traditional | Trisalus Life Sciences | 05/02/2023SE |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | Wallaby Medical | 04/25/2023SE |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus…KRA · Special | Argon Medical Devices, Inc. | 04/10/2023SE |
| K230636 | Maestro MicrocatheterKRA · Special | Merit Medical System, Inc. | 03/30/2023SE |
| K222679 | Vericor Support CatheterKRA · Traditional | Vascupatent Medical (Shenzhen) Co., Ltd. | 11/07/2022SE |
| K213435 | MAGIC Flow-Dependent MicrocatheterKRA · Traditional | Balt USA, LLC | 07/19/2022SE |
| K213442 | Extroducer Infusion Catheter SystemKRA · Traditional | SmartWise Sweden AB | 06/10/2022SE |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterKRA · Special | Medos International SARL | 04/12/2022SE |
| K212719 | Micro Catheter and Guidewire SystemKRA · Traditional | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 04/11/2022SE |
| K211110 | Agile Devices Angler Steerable, Deflectable MicrocatheterKRA · Traditional | Agile Devices, Inc. | 01/07/2022SE |
| K210838 | Prowler Select Plus; Prowler ExKRA · Special | Medos International SARL | 08/25/2021SE |
| K210339 | Bullfrog Micro-Infusion DeviceKRA · Traditional | Mercator Medsystems, Inc. | 08/02/2021SE |
| K211525 | SwiftNINJA Steerable MicrocatheterKRA · Traditional | Merit Medical Systems, Inc. | 07/16/2021SE |
| K210808 | Instylla Microcatheter 1.2KRA · Special | Instylla, Inc. | 04/15/2021SE |
| K210114 | Rebar Micro CatheterKRA · Special | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 02/16/2021SE |
| K202366 | MAGIC Infusion CatheterKRA · Traditional | Balt USA, LLC | 01/29/2021SE |
| K202318 | Marathon Flow Directed Micro CatheterKRA · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 09/14/2020SE |
| K193082 | Fountain ValveTip Infusion CatheterKRA · Traditional | Merit Medical Systems, Inc. | 08/07/2020SE |
| K201907 | ClariVein ICKRA · Special | Merit Medical Systems, Inc. | 08/06/2020SE |
| K201792 | TRUSELECT MicrocatheterKRA · Special | Boston Scientific Corporation | 07/28/2020SE |
| K200582 | Bendit2.7 Steerable MicrocatheterKRA · Traditional | Bend IT Technologies, Ltd. | 06/25/2020SE |
| K200744 | Instylla MicrocatheterKRA · Special | Instylla, Inc. | 04/21/2020SE |
| K191305 | Hereaeus Poseidon MicrocatheterKRA · Traditional | Heraeus Medical Components, LLC | 12/19/2019SE |
| K193107 | TriSalus Infusion SystemKRA · Traditional | Trisalus Life Sciences | 12/03/2019SE |
| K191731 | Instylla MicrocatheterKRA · Traditional | Instylla, Inc. | 08/13/2019SE |
| K182071 | Multi-Sideport Catheter Infusion SetKRA · Traditional | Cook Incorporated | 04/25/2019SE |
| K181684 | VAMP Plus Venous/Arterial Blood Management Protection SystemKRA · Traditional | Edwards Lifesciences, LLC | 11/08/2018SE |
| K180275 | VAMP Optima closed blood sampling systemKRA · Traditional | Edwards Lifesciences, LLC | 10/24/2018SE |
| K173586 | VAMP Venous/Arterial Blood Management Protection SystemKRA · Traditional | Edwards Lifesciences, LLC | 04/05/2018SE |
| K171665 | Microcatheter and guide-wire systemKRA · Traditional | Suzhou Hengrui Disheng Medical Co., Ltd. | 01/11/2018SE |
| K170931 | CXI TriForce Peripheral Crossing SetKRA · Special | Cook Incorporated | 11/13/2017SE |
| K172081 | Maestro MicrocatheterKRA · Special | Merit Medical Systems, Inc. | 08/04/2017SE |
| K163701 | Direxion and Direxion HI-FLO Torqueable MicrocathetersKRA · Special | Boston Scientific Corporation | 05/16/2017SE |
| K161967 | FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmKRA · Traditional | Callisyn Biomedical, Inc. | 01/27/2017SE |
| K161962 | VAMP Venous/Arterial Blood Management Protection SystemKRA · Traditional | Edwards Lifesciences, LLC | 11/28/2016SE |
| K160884 | CXI Support CatheterKRA · Special | Cook Incorporated | 11/22/2016SE |
| K161921 | SwiftNINJA MicrocatheterKRA · Traditional | Merit Medical Systems, Inc. | 11/04/2016SE |
| K161402 | Bullfrog Micro-Infusion DeviceKRA · Traditional | Mercator Medsystems, Inc. | 08/18/2016SE |
| K161801 | CrossCath Support CatheterKRA · Special | Cook Incorporated | 07/29/2016SE |
| K153501 | Bullfrog Micro-Infusion DeviceKRA · Traditional | Mercator Medsystems, Inc. | 04/15/2016SE |
| K152625 | MMS Guide CatheterKRA · Traditional | Micro Medical Solutions, Inc. | 03/09/2016SE |
| K153502 | ClariVein ICKRA · Special | Vascular Insights, LLC | 01/06/2016SE |
| K142259 | Direxion Torqueable MicrocatheterKRA · Special | Boston Scientific Corp | 09/10/2014SE |
| K140329 | Renegade Hi-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom KitKRA · Special | Boston Scientific | 05/15/2014SE |
| K140637 | Peregrine System Infusion CatheterKRA · Traditional | Ablative Solutions, Inc. | 03/26/2014SE |
| K131772 | Cantata(R) 2.9 MicrocatheterKRA · Traditional | Cook, Inc. | 02/20/2014SE |
| K130569 | ND Nabil Dib Infusion CatheterKRA · Traditional | Translational Research Institute | 11/15/2013SE |
| K132947 | Direxion and Direxion Hi-Flo Torqueable MicrocathetersKRA · Special | Boston Scientific Corp | 10/18/2013SE |
| K123477 | Via Microcatheter, Via Plus MicrocatheterKRA · Traditional | Sequent Medical, Inc. | 03/19/2013SE |
| K122796 | Cxi Support CatheterKRA · Special | Cook, Inc. | 10/11/2012SE |
| K113289 | Orion Micro CatheterKRA · Traditional | Micro Therapeutics, Inc. | 08/01/2012SE |
| K113773 | ST Jude Medical, IS4 Flushing/Funneling ToolKRA · Traditional | St Jude Medical | 01/18/2012SE |
| K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…KRA · Special | Ev3, Inc. | 09/16/2011SE |
| K111263 | Cxi TriforceKRA · Traditional | Cook Incorporated | 07/25/2011SE |
| K101450 | Cantata MicrocatheterKRA · Special | Cook, Inc. | 12/30/2010SE |
| K100892 | Renegade Hi-Flo Fathom Kit Model M001182XXXKRA · Special | Boston Scientific Corp | 04/12/2010SE |
| K093750 | Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…KRA · Special | Ev3, Inc. | 12/09/2009SE |
| K093052 | Crosscath Support CathterKRA · Traditional | Cook, Inc. | 12/08/2009SE |
| K091559 | Marksmann CatheterKRA · Traditional | Chestnut Medical Technologies, Inc. | 09/18/2009SE |
| K081147 | Isoflow Infusion CatheterKRA · Traditional | Vascular Designs, Inc. | 05/29/2009SE |
| K090870 | Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and…KRA · Special | Micro Therapeutics, Inc. | 05/01/2009SE |
| K082613 | Merit MicrocatheterKRA · Traditional | Merit Medical Systems, Inc. | 12/30/2008SE |
| K082163 | Flowmedica Benephit Infusion SystemsKRA · Traditional | Flowmedica, Inc. | 10/29/2008SE |
| K082519 | Finecross MG Coronary Micro-Guide CatheterKRA · Traditional | Terumo Medical Corp. | 09/26/2008SE |
| K080737 | Miraflex High Flow MicrocatheterKRA · Special | Cook, Inc. | 08/08/2008SE |
| K053310 | Vascon Roamer MicrocatheterKRA · Traditional | Vascon, LLC | 07/03/2008SE |
| K073166 | Endowave Infusion SystemKRA · Traditional | Ekos Corp. | 04/22/2008SESU |
| K071468 | Clarivein CatheterKRA · Abbreviated | Vascular Insights, LLC | 03/20/2008SE |
| K073400 | Varicath Peripheral Infusion CatheterKRA · Special | Veinrx, Inc. | 12/20/2007SE |
| K072724 | Cxi Support CatheterKRA · Special | Cook, Inc. | 11/09/2007SE |
| K070979 | Pull Tab Squeeze FlushKRA · Special | Icu Medical, Inc. | 09/19/2007SE |
| K070384 | Argon Continuous Flush DeviceKRA · Traditional | Argon Medical Devices, Inc. | 03/29/2007SE |
| K070279 | Modification to Hypertransit Infusion CatheterKRA · Special | Cordis Neurovascular, Inc. | 03/14/2007SE |
| K062752 | Mercator Microsyringe II Infusion CatheterKRA · Traditional | Mercator Medsystems, Inc. | 12/07/2006SE |
| K060224 | Modification to Mira-Flex 18 MicrocatheterKRA · Special | Cook Incorporated | 03/06/2006SE |
| K051990 | Echelon Micro CatheterKRA · Traditional | Micro Therapeutics, Inc. | 01/04/2006SE |
| K052841 | Mira-Flex 18 MicrocatheterKRA · Special | Cook, Inc. | 12/08/2005SE |
| K052738 | Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028…KRA · Special | Veinrx, Inc. | 12/06/2005SE |
| K043538 | Hypertransit Infusion CatheterKRA · Traditional | Cordis Neurovascular, Inc. | 04/18/2005SE |
| K050630 | Pivot Steerable MicrocatheterKRA · Special | Boston Scientific - Precision Vascular | 03/22/2005SE |
| K050205 | Benephit Bifurcated Infusion Catheter and 5FR. Introducer SheathKRA · Special | Flowmedica, Inc. | 03/04/2005SE |
| K042187 | Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon…KRA · Special | Micro Therapeutics, Inc. | 09/02/2004SE |
| K033913 | ProgreatKRA · Traditional | Terumo Medical Corp. | 03/11/2004SE |
| K040139 | Endobionics Microsyringe (Usyringe) Infusion CatheterKRA · Traditional | Endobionics, Inc. | 02/18/2004SE |
| K034036 | Marathon Flow Directed Micro Catheter, Model 105-5055KRA · Traditional | Micro Therapeutics, Inc. | 02/13/2004SE |
| K033726 | PVS Pivot Steerable Delivery System MicrocatheterKRA · Special | Precision Vascular | 01/16/2004SE |
| K033569 | Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathKRA · Traditional | Flowmedica, Inc. | 01/13/2004SE |
| K032494 | PVS 1700 Steerable Delivery System MicrocatheterKRA · Special | Precision Vascular Systems, Inc. | 09/05/2003SE |
| K031992 | Echelon Micro Catheter, Model 105-5091KRA · Special | Micro Therapeutics, Inc. | 08/07/2003SE |
| K030688 | Echelon Micro Catheter, Model 105-5092-150KRA · Special | Micro Therapeutics, Inc. | 03/28/2003SE |
| K024122 | Nautica Micro Catheter, Model 105-5094-153KRA · Traditional | Micro Therapeutics, Inc. | 03/07/2003SE |
| K023351 | Magic Infusion CatheterKRA · Traditional | Advanced Interventional Technologies, LLC | 02/20/2003SE |
| K024118 | Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066KRA · Special | Micro Therapeutics, Inc. | 02/03/2003SE |
| K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsKRA · Special | Cordis Neurovascular, Inc. | 05/22/2002SE |
| K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsKRA · Special | Cordis Neurovascular, Inc. | 03/27/2002SE |
| K020733 | PVS 1500 SDSKRA · Traditional | Precision Vascular Systems, Inc. | 03/21/2002SE |
| K011646 | Neuroedge Infusion CatheterKRA · Traditional | Neuro Vasx, Inc. | 08/27/2001SE |
| K010004 | Flowrider Flow Directed Micro Catheter, Model 105-5065KRA · Special | Micro Therapeutics, Inc. | 02/13/2001SE |
| K003925 | Prowler Infusion Catheters with Pre-Shaped TipsKRA · Special | Cordis Neurovascular, Inc. | 01/08/2001SE |
| K002723 | Rebar Micro Catheter: REBAR-10 (1.7F), 153 CM, Dual Marker Bands; Rebar Micro Catheter:…KRA · Special | Micro Therapeutics, Inc. | 09/28/2000SE |
| K994155 | Excelsior 1018 MicrocatheterKRA · Traditional | Boston Scientific, Target | 08/03/2000SE |
| K001966 | Rebar Micro Catheter: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and…KRA · Special | Micro Therapeutics, Inc. | 07/20/2000SE |
| K000177 | Renegade Hi-Flo MicrocatheterKRA · Traditional | Boston Scientific Corp | 04/07/2000SE |
| K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086KRA · Special | Micro Therapeutics, Inc. | 01/04/2000SE |
| K993266 | Prowler Plus Infusion CatheterKRA · Special | Cordis Neurovascular, Inc. | 10/28/1999SE |
| K983003 | 1 Mass Transit Infusion Catheter, 1 VariousKRA · Special | Cordis Neurovascular, Inc. | 09/17/1998SE |
| K974473 | Easy Rider Micro CatheterKRA · Traditional | Micro Therapeutics, Inc. | 06/17/1998SE |
| K980104 | Flow Rider Flow Directed Micro CatheterKRA · Traditional | Micro Therapeutics, Inc. | 04/10/1998SE |
| K971619 | Microfuse Membrane Infusion CatheterKRA · Traditional | E-Med Corp. | 02/27/1998SE |
| K974222 | Ces Masstransit Infusion CatheterKRA · Traditional | Cordis Neurovascular, Inc. | 02/10/1998SE |
| K973645 | Renegade Fiber Braided MicrocatheterKRA · Traditional | Boston Scientific Corp | 11/19/1997SE |
| K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion CatheterKRA · Traditional | Cordis Neurovascular, Inc. | 11/04/1997SE |
| K971306 | FG Infusion CatheterKRA · Traditional | Cordis Neurovascular, Inc. | 07/14/1997SE |
| K964868 | 2.9F Cragg-Mcnamara Valved Infusion CatheterKRA · Traditional | Micro Therapeutics, Inc. | 05/20/1997SE |
| K962129 | Continuous Flush DeviceKRA · Traditional | Merit Medical Systems, Inc. | 04/15/1997SE |
| K965189 | SpinnakerKRA · Traditional | Target Therapeutics | 03/24/1997SE |
| K965181 | Ces Infusion CatheterKRA · Traditional | Cordis Neurovascular, Inc. | 03/21/1997SE |
| K964154 | Segue Infusion CatheterKRA · Traditional | Interventional Innovations Corp. | 01/14/1997SE |
| K963988 | Intravascular Infusion DeviceKRA · Traditional | Boston Scientific Corp | 12/12/1996SE |
| K961668 | Microferret CatheterKRA · Traditional | Cook, Inc. | 11/04/1996SE |
| K955525 | Flower Infusion Catheter Model F-25/50, F-60/70KRA · Traditional | Interventional Innovations Corp. | 08/08/1996SE |
| K955534 | Seque Infusion Catheter (S-25,30,35,40,45,50,60)KRA · Traditional | International Innovations, Inc. | 08/01/1996SE |
| K961294 | Scimed Dispatch Gold Coronary CatheterKRA · Traditional | Scimed Life Systems, Inc. | 07/03/1996SE |
| K961527 | MX703 and MX730 Continuous Flush DevicesKRA · Traditional | Medex, Inc. | 06/06/1996SE |
| K954457 | Medi-Tech Eddy Intravascular Infusion CatheterKRA · Traditional | Medi-Tech, Inc. | 05/15/1996SE |
| K953133 | Scimed Dispatch Coronary Infusion CatheterKRA · Traditional | Scimed Life Systems, Inc. | 02/23/1996SE |
| K954020 | Micro Therapeutics Sidehole Infusion WireKRA · Traditional | Micro Therapeutics, Inc. | 01/02/1996SE |
| K954949 | Transit Infusion Catheter with SideholesKRA · Traditional | Cordis Neurovascular, Inc. | 12/22/1995SE |
| K952874 | Transit Infusion CatheterKRA · Traditional | Cordis Neurovascular, Inc. | 08/21/1995SE |
| K952872 | Sscimed Coronary Guide Wire/Infusion CatheterKRA · Traditional | Scimed Life Systems, Inc. | 07/27/1995SE |
| K945666 | Evolution(Tm) MicrocatheterKRA · Traditional | Boston Scientific Corp | 06/21/1995SE |
| K951602 | Pulse*Spray Infusion SystemKRA · Traditional | Angiodynamics, Div. E-Z-Em, Inc. | 06/14/1995SE |
| K945909 | Navarre N-Fuser(Tm) Peripheral Infusion CatheterKRA · Traditional | Navarre Biomedical , Ltd. | 06/02/1995SE |
| K945904 | Scimed(R) Venture(Tm) II Infusion CatheterKRA · Traditional | Scimed Peripheral Interventions | 05/19/1995SE |
| K951502 | CVD Bullet Infusion CatyheterKRA · Traditional | Cardiovascular Dynamics, Inc. | 05/10/1995SE |
| K951503 | CVD Bullett Hi-Flo Infusion CatheterKRA · Traditional | Cardiovascular Dynamics, Inc. | 05/04/1995SE |
| K945593 | Scimed(R) Coronary Guide Wire Exchange/Infusion CatheterKRA · Traditional | Scimed Life Systems, Inc. | 01/13/1995SE |
| K935349 | Localmed Infusion CatheterKRA · Traditional | Localmed, Inc. | 10/18/1994SE |
| K931335 | Scimed(R) Venture(Tm) Infusion CatheterKRA · Traditional | Scimed Life Systems, Inc. | 07/27/1994SE |
| K932800 | Cardima Tracker(R) Infusion CatheterKRA · Traditional | Cardima, Inc. | 12/21/1993SE |
| K932616 | Scimed(R) Dispatch(Tm) Coronary Infusion CatheterKRA · Traditional | Scimed Life Systems, Inc. | 12/15/1993SE |
| K932188 | Safeset ReservoirKRA · Traditional | Abbott Laboratories | 10/25/1993SE |
| K921247 | Zephyr Infusion CatheterKRA · Traditional | Target Therapeutics | 06/29/1993SE |
| K914751 | Selective Infusion II CatheterKRA · Traditional | Advanced Cardiovascular Systems, Inc. | 05/24/1993SE |
| K924661 | Swan-Ganz Intellicath Cco Thermodilution CatheterKRA · Traditional | Baxter Healthcare Corp | 04/08/1993SE |
| K923368 | Magic Infusion CatheterKRA · Traditional | Target Therapeutics | 04/07/1993SE |
| K914979 | Edm(R) Infusion CatheterKRA · Traditional | Peripheral Systems Group | 09/16/1992SE |
| K905447 | E-Z-Em Pulsed Infusion SystemKRA · Traditional | E-Z-Em, Inc. | 04/01/1991SE |
| K896819 | Vamp Venous/Arterial Blood Management ProtectionKRA · Traditional | Baxter Healthcare Corp | 01/19/1990SE |
| K885281 | Vamp Venous/Arterial Blood Management ProtectionKRA · Traditional | Baxter Healthcare Corp | 03/03/1989SE |
| K884946 | Jehle Coronary Perfusion CathetersKRA · Traditional | Pilling Co. | 02/06/1989SE |
| K874242 | Jehle Coronary Perfusion CathetersKRA · Traditional | Pilling Co. | 12/07/1987SE |
| K860570 | Angio-Flo Continuous Arterial Cath Flush DeviceKRA · Traditional | Parke-Davis Co. | 03/31/1986SE |
| K832058 | Angio-Flo Contin-Arterial Flush Dev.KRA · Traditional | Parke-Davis Co. | 09/12/1983SE |
| K831730 | Continuous Flush DeviceKRA · Traditional | American Pharmaseal Div. Ahsc | 07/18/1983SE |
| K831637 | Accu-FlushKRA · Traditional | Accu-Line | 06/30/1983SE |
| K812173 | Flushflo IIKRA · Traditional | Bentley Laboratories, Inc. | 08/18/1981SE |
| K811410 | Medi-TraceKRA · Traditional | Graphic Controls Corp. | 06/12/1981SE |
| K801829 | Medi-Trace Disp. Flushing Dev./MonitorKRA · Traditional | Graphic Controls Corp. | 08/27/1980SE |
| K801173 | Angio-Flo Monitoring KitKRA · Traditional | Hospital Products Co. | 05/28/1980SE |
| K791890 | Continuous Flush Device, Cat. #14-370KRA · Traditional | Norton Performance Plastics Corp. | 12/13/1979SE |
| K792141 | Continuous Flush DeviceKRA · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 12/05/1979SE |
| K791844 | Critiflo & Critiflo DomeKRA · Traditional | Gould, Inc. | 10/02/1979SE |
| K790455 | MicroflushKRA · Traditional | Medex, Inc. | 03/23/1979SE |
| K790327 | Angio-FloKRA · Traditional | Deseret Medical, Inc. | 02/26/1979SE |
| K780479 | Delta-FlowKRA · Traditional | Tri-Delta Intl. | 11/22/1978SE |
| K770432 | MicroflushKRA · Traditional | Medex, Inc. | 03/16/1977SE |
| K761273 | Flushflo-Model CC1-6KRA · Traditional | Bentley Laboratories, Inc. | 01/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1010-2024 Class II | PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045…Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during… | Angiodynamics, Inc. | 12/18/2023Open, Classified |
| Z-0627-2024 Class II | Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B…The sterility of microcatheter and infusion system devices cannot be guaranteed. | Merit Medical Systems, Inc. | 11/06/2023Open, Classified |
| Z-1557-2022 Class II | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx OnlyOuter carton packaging of microcatheters were exposed to wet substance during transport. | Micro Therapeutics, Inc. | 06/30/2022Open, Classified |
| Z-1556-2022 Class II | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx OnlyOuter carton packaging of microcatheters were exposed to wet substance during transport. | Micro Therapeutics, Inc. | 06/30/2022Open, Classified |
| Z-0637-2021 Class II | EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS)…This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has… | Boston Scientific Corporation | 11/03/2020Open, Classified |
| Z-0590-2020 Class I | CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | Cook Inc. | 11/08/2019Terminated |
| Z-0589-2020 Class I | CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | Cook Inc. | 11/08/2019Terminated |
| Z-0588-2020 Class I | CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | Cook Inc. | 11/08/2019Terminated |
| Z-0587-2020 Class I | CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | Cook Inc. | 11/08/2019Terminated |
| Z-1146-2018 Class II | ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC…Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result… | Vascular Insights, LLC | 11/09/2017Terminated |
| Z-1393-2017 Class II | TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film…Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an… | Cook Inc. | 02/01/2017Terminated |
| Z-0309-2017 Class I | Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter…Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 10/05/2016Terminated |
| Z-0114-2017 Class II | VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is…Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the… | Sequent Medical Inc | 09/23/2016Terminated |
| Z-2854-2016 Class II | EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterThe recalling firm identified ten devices which were distributed and could potentially be non-compliant.… | EKOS Corporation | 08/09/2016Terminated |
| Z-0864-2016 Class II | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main…The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery… | EKOS Corporation | 01/21/2016Terminated |
| Z-0244-2016 Class II | Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for…Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being… | Cook Inc. | 10/21/2015Terminated |
| Z-2148-2015 Class II | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic…The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. | EKOS Corporation | 06/24/2015Terminated |
| Z-1365-2015 Class II | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only.…Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral… | Medtronic Inc. Cardiac Rhythm Disease… | 03/23/2015Terminated |
| Z-1018-2015 Class I | Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015…A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port… | Covidien | 12/10/2014Terminated |
| Z-1017-2015 Class I | Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01…A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port… | Covidien | 12/10/2014Terminated |
| Z-0162-2015 Class II | Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic…These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. | Merit Medical Systems, Inc. | 09/26/2014Terminated |
| Z-2262-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | Angiodynamics, Inc. | 08/06/2014Terminated |
| Z-2261-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | Angiodynamics, Inc. | 08/06/2014Terminated |
| Z-2260-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | Angiodynamics, Inc. | 08/06/2014Terminated |
| Z-0614-2014 Class II | Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular…Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic… | Merit Medical Systems, Inc. | 12/06/2013Terminated |
| Z-0133-2014 Class II | The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585…The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is… | EKOS Corporation | 10/02/2013Terminated |
| Z-1146-2013 Class II | Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A…The device is being recalled because the firm has received multiple complaints related to incorrect assembly… | Edwards Lifesciences, LLC | 01/30/2013Terminated |
| Z-2023-2012 Class II | EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124…EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on… | EKOS Corporation | 05/24/2012Terminated |
| Z-1114-2012 | AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System ---…The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. | Angiodynamics Worldwide Headquarters | 02/06/2012Terminated |
| Z-1113-2012 | AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System ---…The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. | Angiodynamics Worldwide Headquarters | 02/06/2012Terminated |
| Z-1112-2012 | AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System ---…The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. | Angiodynamics Worldwide Headquarters | 02/06/2012Terminated |
| Z-0509-2012 | Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035…The Benephit XT Infusion System may contain hairline cracks in the sheath hub. | Angiodynamics Worldwide Headquarters | 12/05/2011Terminated |
| Z-2472-2012 Class II | Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow…The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 09/23/2011Terminated |
| Z-2471-2012 Class II | UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The…The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 09/23/2011Terminated |
| Z-3267-2011 | ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819…The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires. | Angiodynamics Worldwide Headquarters | 01/28/2011Terminated |
| Z-3266-2011 | ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401818…The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires. | Angiodynamics Worldwide Headquarters | 01/28/2011Terminated |
| Z-1707-2010 | PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402…This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length… | Angiodynamics, Inc. | 05/17/2010Terminated |
| Z-1734-2010 | ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion…Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product… | Angiodynamics, Inc. | 04/30/2010Terminated |
| Z-1733-2010 | ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion…Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product… | Angiodynamics, Inc. | 04/30/2010Terminated |
| Z-0894-2010 | Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0893-2010 | Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0892-2010 | Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0891-2010 | Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0890-2010 | Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0889-2010 | Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0888-2010 | Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0887-2010 | Mistique Infusion Catheter, MIC5-135-10-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0886-2010 | Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0885-2010 | Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |
| Z-0884-2010 | Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc.…Infusion catheters may become brittle and break during use. | Merit Medical Systems, Inc. | 01/06/2010Terminated |