Catheter, Intravascular, Diagnostic
FDA product code DQO · Class II (moderate risk) · 21 CFR 870.1200 · Cardiovascular
501510(k) clearances
0PMA approvals
254recalls
Manufacturers
- Cordis Corp. 29
- Boston Scientific Corporation 20
- Scimed Life Systems, Inc. 16
- C.R. Bard, Inc. 16
- Cook, Inc. 15
- Vascular Solutions, Inc. 12
- Angiodynamics, Inc. 11
- Target Therapeutics 10
- Mallinckrodt Critical Care 9
- Abbott Laboratories 9
- Cardiovascular Imaging Systems, Inc. 8
- Merit Medical Systems, Inc. 8
- Surefire Medical, Inc. 7
- Terumo Medical Corp. 6
- Advanced Cardiovascular Systems, Inc. 6
- Micrus Endovascular Corporation 6
- American Edwards Laboratories 6
- Vertex Medical Corp. 6
- Concentric Medical, Inc. 6
- Boston Scientific Scimed, Inc. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 08/08/2023SE |
| K231293 | Drakon and Sequre® MicrocathetersDQO · Special | Accurate Medical Therapeutics | 06/01/2023SE |
| K230411 | Dragonfly OpStar Imaging CatheterDQO · Traditional | Abbott Medical | 04/14/2023SE |
| K221279 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/28/2022SE |
| K213666 | NuCath Wedge Pressure CatheterDQO · Traditional | Pfm Medical, Inc. | 10/06/2022SE |
| K221470 | Langston dual lumen catheterDQO · Special | Vascular Solutions, LLC | 06/17/2022SE |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbandsDQO · Traditional | Cordis Corporation | 02/17/2022SE |
| K211078 | Progreat LambdaDQO · Traditional | Terumo Clinical Supply Co., Ltd. | 12/21/2021SE |
| K203487 | Drakon and Sequre MicrocathetersDQO · Special | Accurate Medical Therapeutics, Ltd. | 12/11/2020SE |
| K202797 | Drakon and Sequre MicrocathetersDQO · Special | Accurate Medical Therapeutics, Ltd. | 10/23/2020SE |
| K193647 | Superpipe Angiographic CatheterDQO · Traditional | Suzhou Hengrui Disheng Medical Co., Ltd. | 07/29/2020SE |
| K192267 | ILUMIEN System with AptiVue Software version D.3DQO · Special | Abbott Medical | 12/17/2019SE |
| K192122 | Trevo Trak 21 MicrocatheterDQO · Traditional | Stryker | 11/22/2019SE |
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1DQO · Traditional | Abbott Medical | 11/08/2019SE |
| K190126 | Bendit2.7 Steerable MicrocatheterDQO · Traditional | Bend IT Technologies, Ltd. | 08/22/2019SE |
| K191608 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 07/16/2019SE |
| K181722 | Polyethylene CatheterDQO · Traditional | Cook Incorporated | 03/22/2019SE |
| K180846 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Cook Incorporated | 12/19/2018SESK |
| K180792 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Cook Incorporated | 11/30/2018SE |
| K180286 | Polyethylene CatheterDQO · Traditional | Cook Incorporated | 10/26/2018SE |
| K180054 | Royal Flush Plus High-Flow CatheterDQO · Traditional | Cook Incorporated | 10/05/2018SE |
| K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo…DQO · Special | Cordis, A Cardinal Health Company | 08/08/2018SE |
| K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersDQO · Special | AngioDynamics, Inc. | 07/18/2018SE |
| K180677 | Surefire Spark Infusion SystemDQO · Traditional | Surefire Medical, Inc. | 04/03/2018SE |
| K172635 | High-Flo Silver Polyethylene CatheterDQO · Traditional | Cook Incorporated | 04/03/2018SE |
| K173430 | SeQure® NF and SeQure® MicrocathetersDQO · Traditional | Accurate Medical Therapeutics, Ltd. | 01/26/2018SE |
| K171264 | Royal Flush CatheterDQO · Traditional | Cook Incorporated | 01/25/2018SE |
| K170544 | Langston dual lumen catheterDQO · Traditional | Vascular Solutions, Inc. | 11/17/2017SE |
| K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle…DQO · Special | Cook Incorporated | 11/15/2017SE |
| K170223 | ProgreatDQO · Traditional | Ashitaka Factory of Terumo Corporation | 07/21/2017SE |
| K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterDQO · Traditional | Cook Incorporated | 05/26/2017SE |
| K171355 | Surefire Precision Infusion SystemDQO · Special | Surefire Medical, Inc. | 05/17/2017SE |
| K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic CathetersDQO · Traditional | AngioDynamics, Inc. | 04/28/2017SE |
| K170406 | Plato MICROCATH 27B MicrocatheterDQO · Traditional | Scientia Vascular, LLC | 04/18/2017SE |
| K162789 | Foresight Intracardiac Echocardiology (ICE) SystemDQO · Traditional | Conavi Medical, Inc. | 03/28/2017SE |
| K160660 | Medline Waste StationDQO · Traditional | Medline Industries, Inc. | 01/19/2017SE |
| K163141 | NAMIC ClearaCIL Contrast Injection LinesDQO · Traditional | AngioDynamics, Inc. | 01/06/2017SE |
| K161822 | Torcon NB Advantage CathetersDQO · Special | Cook Incorporated | 10/27/2016SE |
| K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit…DQO · Traditional | Medtronic Vascular | 08/19/2016SESK |
| K160662 | Surefire Infusion SystemDQO · Special | Surefire Medical, Inc. | 03/11/2016SE |
| K153125 | IntraNovo MicrocatheterDQO · Special | Texasmedical Technologies, Inc. | 01/13/2016SE |
| K151126 | Foresight Intracardiac Echocardiography (ICE) SystemDQO · Traditional | Colibri Technologies, Inc. | 12/18/2015SE |
| K152605 | Impulse Angiographic Catheter, Expo Angiographic CatheterDQO · Special | Boston Scientific Corporation | 10/29/2015SE |
| K150232 | Radifocus Optitorque Angiographic CatheterDQO · Traditional | Ashitaka Factory of Terumo Corp. | 10/19/2015SE |
| K151724 | AngioDynamics Mariner Angiographic CathetersDQO · Special | AngioDynamics, Inc. | 10/14/2015SE |
| K143398 | Plato MICROCATH 27B MicrocatheterDQO · Traditional | Scientia Vascular, LLC | 06/26/2015SE |
| K143604 | Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic…DQO · Traditional | Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S | 06/25/2015SE |
| K142817 | IntraNovo 25 MicrocatheterDQO · Traditional | Texasmedical Technologies, Inc. | 04/23/2015SE |
| K140356 | Summed High Pressure LineDQO · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 03/20/2015SE |
| K143588 | Surefire Infusion System 021DQO · Traditional | Surefire Medical, Inc. | 01/12/2015SE |
| K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterDQO · Traditional | Cook, Inc. | 01/09/2015SE |
| K141453 | Ilumien Optis, Dragonfly Optis Imaging CatheterDQO · Traditional | Lightlab Imaging, Inc. | 09/19/2014SE |
| K141769 | Optis Integrated System, Dragonfly Optis Imaging CatheterDQO · Traditional | Lightlab Imaging, Inc. | 08/18/2014SE |
| K131770 | Pressure Connecting TubeDQO · Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 02/26/2014SE |
| K131437 | Modified Concentric MicrocatheterDQO · Traditional | Concentric Medical, Inc. | 10/11/2013SE |
| K123818 | Ursa Angiographic CatheterDQO · Special | Curative Medical Technology, Inc. | 03/04/2013SE |
| K122937 | Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath…DQO · Special | Cook, Inc. | 12/14/2012SE |
| K121694 | Imager II Angiographic CatheterDQO · Traditional | Boston Scientific Corp | 09/14/2012SE |
| K120008 | Medline High Pressure Injection TubingDQO · Traditional | Medline Industries, Inc. | 08/17/2012SE |
| K120917 | Headway Duo MicrocatheterDQO · Traditional | MicroVention, Inc. | 08/02/2012SE |
| K121734 | Plato Microcath 27 MicrocatheterDQO · Traditional | Scientia Vascular, LLC | 07/30/2012SE |
| K121954 | Nmi MicrocatheterDQO · Special | Navilyst Medical, Inc. | 07/17/2012SE |
| K113335 | Heartrail III Guiding CatheterDQO · Special | Terumo Corporation | 07/16/2012SE |
| K113819 | Mongoose Angiographic CatheterDQO · Traditional | Pediacath, Inc. | 07/11/2012SE |
| K121677 | Surefire Hi-Flow MicrocatheterDQO · Traditional | Surefire Medical, Inc. | 06/14/2012SE |
| K120495 | Impulse and Expo Angiographic CatheterDQO · Special | Boston Scientific Corp | 05/21/2012SE |
| K112452 | Angiodynamics Soft-Vu Angiographic CathetersDQO · Special | AngioDynamics, Inc. | 03/30/2012SE |
| K120893 | Imager II Angiographic CathetersDQO · Special | Boston Scientific Corp | 03/29/2012SE |
| K113260 | Modified Concentirc MicrocatheterDQO · Special | Concentric Medical, Inc. | 03/09/2012SE |
| K113737 | Surefire Guide SheathDQO · Special | Surefire Medical, Inc. | 02/23/2012SE |
| K113638 | Nmi 2.8 MicrocatheterDQO · Special | Navilyst Medical, Inc. | 01/05/2012SE |
| K102633 | Bioteq Angiographic CatheterDQO · Traditional | Bioteque Corp. | 09/09/2011SE |
| K112124 | MicrocatheterDQO · Abbreviated | Navilyst Medical, Inc. | 08/19/2011SE |
| K111619 | Modified Concentric MicrocatheterDQO · Special | Concentric Medical, Inc. | 07/06/2011SE |
| K110643 | Merit Marquis Flow SwitchDQO · Traditional | Merit Medical Systems, Inc. | 07/01/2011SE |
| K110459 | Surefire Infusion Catheter SystemDQO · Traditional | Surefire Medical, Inc. | 06/24/2011SE |
| K110103 | Edwards Lifesciences Left Atrial Pressure Monitor CatheterDQO · Special | Edwards Lifesciences, LLC | 02/11/2011SE |
| K101625 | Cohen Crossover CatheterDQO · Traditional | Vascular Solutions, Inc. | 07/19/2010SE |
| K101669 | Thermodilution CatheterDQO · Special | Biosensors Intl. Pte. , Ltd. | 07/01/2010SE |
| K101239 | Viewflex Plus Ice CatheterDQO · Special | St Jude Medical | 06/02/2010SE |
| K093004 | Impress Angiographic Catheter with Hydrophilic CoatingDQO · Traditional | Merit Medical Systems, Inc. | 02/12/2010SE |
| K090427 | Ursa Angiographic CatheterDQO · Traditional | Curative Medical Technology, Inc. | 01/29/2010SE |
| K092118 | Angiographic Catheter, Model AngiosDQO · Traditional | Oscor, Inc. | 01/13/2010SE |
| K083384 | Thermodilution CatheterDQO · Special | Biosensors Intl. Pte. , Ltd. | 01/05/2010SE |
| K092702 | Micrus Microcatheter, Model Courier 270DQO · Special | Micrus Endovascular Corporation | 11/20/2009SE |
| K091780 | Guided Measurement Catheter (GMC)DQO · Traditional | Mediguide, Ltd. | 10/16/2009SE |
| K092372 | Heartrail III Guiding CatheterDQO · Traditional | Terumo Corp. | 09/11/2009SE |
| K091961 | Modified Concentric Microcatheter, Model 90047DQO · Special | Concentric Medical, Inc. | 07/30/2009SE |
| K083922 | Micrus Microcatheter, Courier Flex, Model MSF 170000-00DQO · Special | Micrus Endovascular Corporation | 05/06/2009SE |
| K090276 | Acuson X300 Diagnostic Ultrasound SystemDQO · Traditional | Siemens Medical Solutions USA, Inc. | 02/19/2009SE |
| K090040 | Radifocus Glidecath (or Radifocus Glidecath XP)DQO · Traditional | Terumo Medical Corp. | 02/06/2009SE |
| K081846 | Grebset Micro-Introducer Kit, Models 7950, 7951DQO · Traditional | Vascular Solutions, Inc. | 01/28/2009SE |
| K082736 | Radifocus Optitorque Angiographic CatheterDQO · Traditional | Terumo Medical Corp. | 09/24/2008SE |
| K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905DQO · Traditional | Vascular Solutions, Inc. | 04/17/2008SE |
| K073200 | Gandras Intravascular Catheter, Models 5580, 5581 and 5582DQO · Traditional | Vascular Solutions, Inc. | 02/01/2008SE |
| K072796 | Meerci Retriever, Concentric Microcatheter, Models 90050, 90060, 90065, 90066…DQO · Special | Concentric Medical, Inc. | 12/18/2007SE |
| K072526 | Micrus Courier Enzo Microcatheter 0.0190DQO · Special | Micrus Endovascular Corporation | 10/05/2007SE |
| K071196 | Disposable High Pressure Injection Lines with and Without Rotating AdaptersDQO · Traditional | Coeur, Inc. | 09/06/2007SE |
| K070456 | Micrus Courier Enzo Microcatheter 0.017DQO · Special | Micrus Endovascular Corporation | 05/24/2007SE |
| K063784 | Dye Management SystemDQO · Special | Icu Medical, Inc. | 04/16/2007SE |
| K070011 | Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging CatheterDQO · Traditional | Irvine Biomedical,Inc.(Ibi) | 03/20/2007SE |
| K062877 | Twin-Pass .023 Dual Access Catheter, Model 5230DQO · Traditional | Vascular Solutions, Inc. | 01/18/2007SE |
| K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905DQO · Traditional | Vascular Solutions, Inc. | 01/05/2007SE |
| K063312 | Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model 39014 and…DQO · Special | Boston Scientific Corp | 11/30/2006SE |
| K061733 | Angiodynamics Soft-Vu and Mariner Hydrophilic Coated Angiographic CatheterDQO · Special | AngioDynamics, Inc. | 08/24/2006SE |
| K062126 | Embocath Plus Infusion Microcatheter, Model ECP-100 and ECP-135DQO · Special | Biosphere Medical, Inc. | 08/09/2006SE |
| K061963 | Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…DQO · Special | Micrus Endovascular Corporation | 08/04/2006SE |
| K060010 | NautifluxDQO · Traditional | Sedat | 08/04/2006SE |
| K061565 | Langston Dual Lumen CatheterDQO · Traditional | Vascular Solutions, Inc. | 08/02/2006SE |
| K052908 | Intraredx Nir Imaging System, Model MC-5DQO · Traditional | Infraredx, Inc. | 06/23/2006SE |
| K060116 | Micrus Courier MicrocathetersDQO · Traditional | Micrus Endovascular Corporation | 05/12/2006SE |
| K060175 | Isight Imaging Catheter, Model 38986DQO · Special | Boston Scientific Corp | 03/24/2006SE |
| K052637 | Therox Infusion Catheter, Model INCA-1DQO · Traditional | Therox, Inc. | 03/08/2006SE |
| K053171 | Merit Impress Diagnostic CatheterDQO · Traditional | Merit Medical Systems, Inc. | 01/19/2006SE |
| K052865 | Hospira Cath Lab Convenience KitsDQO · Special | Icu Medical, Inc. | 12/22/2005SE |
| K051561 | Asahi Angiographic CatheterDQO · Traditional | Asahi Intecc Co., Ltd. | 11/02/2005SE |
| K050863 | Imager II Angiographic CatheterDQO · Traditional | Boston Scientific Corp | 09/02/2005SE |
| K051395 | Langston Dual Lumen Pressure Monitoring CatheterDQO · Traditional | Vascular Solutions, Inc. | 06/24/2005SE |
| K050371 | Medrad Vanguard DX Angiographic CatheterDQO · Traditional | Medrad, Inc. | 06/07/2005SE |
| K050684 | Atlantis PVDQO · Special | Boston Scientific Corp | 05/20/2005SE |
| K050168 | Langston Dual Lumen Pressure Monitoring CatheterDQO · Traditional | Vascular Solutions, Inc. | 05/18/2005SE |
| K050577 | Atlantis SR PRO2 Coronary Imaging Catheter, Model 39014DQO · Special | Boston Scientific Corp | 03/30/2005SE |
| K042685 | Metricath SystemDQO · Traditional | Angiometrx, Inc. | 11/18/2004SE |
| K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)DQO · Traditional | Vascular Solutions, Inc. | 09/23/2004SE |
| K041123 | Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703DQO · Traditional | Kerberos Proximal Solutions, Inc. | 08/26/2004SESU |
| K034043 | H-Flow ValveDQO · Traditional | Elcam Medical Acal | 06/30/2004SE |
| K040830 | Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersDQO · Special | NuMED, Inc. | 06/18/2004SE |
| K041291 | Rinspiration SystemDQO · Special | Kerberos Proximal Solutions, Inc. | 05/21/2004SE |
| K040776 | Atlantis SR, Model C4020; Atlantis SR Plus, Model 35975DQO · Special | Boston Scientific Corp | 04/29/2004SE |
| K032888 | Creation NM Diagnostic CathetersDQO · Traditional | Neich Medical (Shenzhen) Company Limited | 02/24/2004SE |
| K033583 | ProgreatDQO · Special | Terumo Medical Corp. | 12/12/2003SE |
| K031599 | CD Leycom Pressure/Volume CathetersDQO · Special | Cd Leycom BV | 12/09/2003SE |
| K031485 | Rinspiration SystemDQO · Traditional | Kerberos Proximal Solutions | 09/25/2003SE |
| K032624 | Micrus MicrocatheterDQO · Traditional | Micrus Corp. | 09/10/2003SE |
| K032376 | Angiodynamics Accu-Vu Sizing Angiographic CatheterDQO · Special | AngioDynamics, Inc. | 08/26/2003SE |
| K024000 | Metricath System Comprised of Metricath 1000 Console & Metricath Balloon CatheterDQO · Traditional | Angiometrx, Inc. | 06/26/2003SE |
| K023591 | Ultra High Pressure Injector LinesDQO · Traditional | Deroyal Industries, Inc. | 06/18/2003SE |
| K022004 | Cardiac Output Kit, Model CO-1 & Inline Sensor Cable, Model ILS-1DQO · Traditional | Biosensors International-USA | 03/12/2003SE |
| K024126 | Clear or Braided Contrast Media Injection Line or Without Rotator, Cath Lab KitDQO · Special | Abbott Laboratories | 01/14/2003SE |
| K023681 | Renegade STC 18 MicrocatheterDQO · Special | Boston Scientific Corp | 11/26/2002SE |
| K022621 | Boston Scientific Imager II 4F Selective Angiographic CatheterDQO · Special | Boston Scientific Corp | 09/04/2002SE |
| K021283 | Guidant Balloon Catheter, Several ModelsDQO · Traditional | Guidant Corp. | 05/02/2002SE |
| K021015 | Acist Plus 4 Angiographic CatheterDQO · Special | Acist Medical Systems | 04/26/2002SE |
| K020890 | Spyglass 4 FR Angiographicy CatheterDQO · Special | St Jude Medical | 04/17/2002SE |
| K020316 | Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…DQO · Traditional | Cordis Corp. | 03/20/2002SE |
| K012983 | Acist 4 French Angiographic CatheterDQO · Traditional | Acist Medical Systems, Inc. | 03/13/2002SE |
| K014054 | Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon MaterialDQO · Traditional | Edwards Lifesciences, LLC | 03/08/2002SE |
| K020012 | Modification to Renegade Fiber Braided MicrocatheterDQO · Special | Boston Scientific/Medi-Tech | 01/29/2002SE |
| K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664DQO · Traditional | Biocardia, Inc. | 01/24/2002SE |
| K011664 | Imager II Angiographic CatheterDQO · Special | Boston Scientific/Medi-Tech | 09/07/2001SE |
| K003288 | Origen Dual Lumen CatheterDQO · Traditional | Origen Biomedical, Inc. | 06/08/2001SE |
| K003105 | Biosphere Medical Infusion CatheterDQO · Traditional | Biosphere Medical | 05/22/2001SE |
| K011217 | Clear or Braided Contrast Media Injection Line with or Without Rotator, Cath Lab KitDQO · Special | Abbott Laboratories | 05/16/2001SE |
| K003086 | Concentric Micro Catheter, Models 90001 to 90008DQO · Traditional | Concentric Medical, Inc. | 05/16/2001SE |
| K003020 | Cardiac Function Laboratory; Pressure Interface; Pressure / Volume CatheterDQO · Traditional | Cd Leycom BV | 05/11/2001SE |
| K010707 | Atlantis SR Plus Coronary Imaging Catheter, Model 35975DQO · Special | Boston Scientific, Target | 03/29/2001SE |
| K002254 | Cook Pressure Monitoring CatheterDQO · Traditional | Cook, Inc. | 03/16/2001SE |
| K003938 | Trak Back IIDQO · Special | Jomed, Inc. | 01/18/2001SE |
| K003901 | Angiodynamics Soft-Vu Sizing Angiographic CatheterDQO · Special | AngioDynamics, Inc. | 01/17/2001SE |
| K003902 | Multitrack Angiographic CatheterDQO · Special | NuMED, Inc. | 01/11/2001SE |
| K001578 | Angiodynamics Soft-Vu Hydrophilic Coated Angiographic CatheterDQO · Special | AngioDynamics, Inc. | 10/13/2000SE |
| K000825 | 4F-7F Medi-Dyne Torq Flow XLB Angiographic CatheterDQO · Traditional | Medi-Dyne, Inc. | 09/21/2000SE |
| K002416 | Golden-Rule Scaling CatheterDQO · Traditional | Medical Device Technologies, Inc. | 09/11/2000SE |
| K000743 | Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020DQO · Traditional | Boston Scientific Scimed, Inc. | 09/06/2000SE |
| K000820 | Avanar F/X 2.9F Intravascular Ultrasound Imaging Catheter, Model 85700DQO · Special | Endosonics Corp. | 06/05/2000SE |
| K000579 | Tempo Aqua Angiographic CatheterDQO · Special | Cordis Corp. | 05/03/2000SE |
| K000956 | Modification to Scimed 6F Impulse Angiographic CathatersDQO · Special | Boston Scientific Scimed, Inc. | 04/21/2000SE |
| K000659 | Modification to Softouch Diagnostic Intravascular CatDQO · Special | Merit Medical Systems, Inc. | 03/29/2000SE |
| K993694 | Mikro-Tip Angiographic CatheterDQO · Special | Millar Instruments, Inc. | 03/01/2000SE |
| K990173 | Pathfinder II Angiographic CatheterDQO · Traditional | Maxxim Medical | 12/21/1999SE |
| K992631 | Acunav Diagnostic Ultrasound CatheterDQO · Traditional | Acuson Corp. | 12/15/1999SE |
| K992347 | Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker BandsDQO · Traditional | Cordis Corp. | 10/08/1999SE |
| K992123 | Scimed Impulse Angiographic CathetersDQO · Traditional | Boston Scientific Scimed, Inc. | 08/23/1999SE |
| K992051 | Radifocus OptitorqueDQO · Special | Terumo Medical Corp. | 08/10/1999SE |
| K984627 | Ave 4F Siteseer Cardiovascular Angiographic CatheterDQO · Traditional | Arterial Vascular Engineering, Inc. | 07/27/1999SE |
| K992142 | Scimed Angiographic CathetersDQO · Special | Scimed | 07/21/1999SE |
| K991673 | Cordis Tempo Angiography CatheterDQO · Special | Cordis Corp. | 05/26/1999SE |
| K984258 | Neurovasx Sub-Microinfusion CatheterDQO · Traditional | Neuro Vasx, Inc. | 02/11/1999SE |
| K980973 | Medtronic Angiographic CatheterDQO · Traditional | Medtronics Interventional Vascular | 12/10/1998SE |
| K971616 | Blood Pressure Measurement SYSTEM(DSPM-70)DQO · Traditional | Data Sciences Intl., Inc. | 11/04/1998SE |
| K982299 | Spyglass 5 FR Angiographic CatheterDQO · Traditional | Daig Corp. | 10/19/1998SE |
| K974774 | Envy Guiding CatheterDQO · Traditional | Cook, Inc. | 10/16/1998SE |
| K981788 | Scimed 6 French Wiseguide Guide CatheterDQO · Traditional | Scimed Life Systems, Inc. | 08/18/1998SE |
| K982077 | Selector Diagnostic CatheterDQO · Traditional | Boston Scientific Scimed, Inc. | 08/11/1998SE |
| K981441 | Heart Cath Tray, Sterile, DisposableDQO · Traditional | Trinity Laboratories, Inc. | 07/10/1998SE |
| K980575 | Siteseer Angiographic CatheterDQO · Traditional | C.R. Bard, Inc. | 05/15/1998SE |
| K974559 | Scimed 6 French Impulse Angiographic CathetersDQO · Traditional | Scimed Life Systems, Inc. | 02/23/1998SE |
| K973401 | Tempo 4 Angiography Catheter (Various)DQO · Traditional | Cordis Corp. | 11/18/1997SE |
| K964210 | Retriever IIDQO · Traditional | Target Therapeutics | 10/31/1997SE |
| K963335 | Harmac Balloon Wedge Pressure CatheterDQO · Traditional | Harmac Medical Products, Inc. | 10/16/1997SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3214-2026 | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER…Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through… | Boston Scientific Corporation | 08/24/2026Open, Classified |
| Z-1936-2026 Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | Cook Incorporated | 04/02/2026Open, Classified |
| Z-1935-2026 Class I | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | Cook Incorporated | 04/02/2026Open, Classified |
| Z-1934-2026 Class I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | Cook Incorporated | 04/02/2026Open, Classified |
| Z-1823-2026 Class II | Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software… | Gentuity, LLC | 03/23/2026Open, Classified |
| Z-1778-2026 Class II | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Cook Incorporated | 03/05/2026Open, Classified |
| Z-1875-2026 Class II | AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1874-2026 Class II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1873-2026 Class II | AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1872-2026 Class II | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1871-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1870-2026 Class II | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1869-2026 Class II | Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1868-2026 Class II | Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1867-2026 Class II | Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1866-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1865-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1864-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1863-2026 Class II | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1862-2026 Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1861-2026 Class II | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1860-2026 Class II | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1859-2026 Class II | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1858-2026 Class II | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1857-2026 Class II | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1856-2026 Class II | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH…The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from… | Angiodynamics, Inc. | 03/03/2026Open, Classified |
| Z-1902-2025 Class I | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and…Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. | Cook Incorporated | 05/15/2025Open, Classified |
| Z-2454-2024 Class II | SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog…Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner… | Angiodynamics, Inc. | 06/18/2024Open, Classified |
| Z-2453-2024 Class II | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog…Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner… | Angiodynamics, Inc. | 06/18/2024Open, Classified |
| Z-1904-2024 Class II | Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238Neurovascular devices did not meet the minimum sample size required for endotoxin testing during… | Stryker Neurovascular | 04/23/2024Open, Classified |
| Z-1685-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1684-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1683-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1682-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1681-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1680-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1679-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1678-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1677-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1676-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1675-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1674-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1673-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1672-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1671-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1670-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1669-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1668-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1667-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |
| Z-1666-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | Boston Scientific Corporation | 03/21/2024Open, Classified |