Clamp, Vascular
FDA product code DXC · Class II (moderate risk) · 21 CFR 870.4450 · Cardiovascular
205510(k) clearances
0PMA approvals
26recalls
Manufacturers
- Radi Medical Systems AB 8
- Cardiva Medical, Inc. 7
- Novare Surgical Systems, Inc. 6
- Advanced Vascular Dynamics 6
- Applied Vascular Devices, Inc. 5
- Heartport, Inc. 5
- Edwards Lifesciences, LLC 5
- Rmds, Inc. 4
- Vascular Control Systems, Inc. 4
- Innovative Trauma Care, Inc. 4
- Merit Medical Systems, Inc. 3
- Tz Medical, Inc. 3
- Y. Daneshvar 3
- Compression Works, LLC 3
- Allegiance Healthcare Corp. 3
- Cardiothoracic Systems, Inc. 3
- Vascular Solutions, Inc. 3
- Terumo Medical Corp. 3
- Combat Medical Systems, LLC 3
- Bio-Vascular, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | Merit Medical Systems, Inc. | 07/22/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
| K252772 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | Tz Medical, Inc. | 05/22/2026SE |
| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional | Arc Trauma, LLC | 12/31/2025SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
| K222182 | Radial Artery Compression TourniquetsDXC · Traditional | Beijing Demax Medical Technology Co.,Ltd | 01/04/2023SE |
| K221843 | GEM Biover Microvascular ClampsDXC · Special | Synovis Micro Companies Alliance, Inc. | 09/14/2022SE |
| K213531 | TR BAND Radial Compression DeviceDXC · Traditional | Terumo Medical Corporation | 12/20/2021SE |
| K210681 | SiteSeal SVDXC · Special | Ensite Vascular | 04/06/2021SE |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186DXC · Special | Carefusion 2200, Inc. | 03/04/2021SE |
| K210006 | MI DeTACHDXC · Traditional | Biorep Technologies, Inc. | 03/04/2021SE |
| K203307 | ViolaDXC · Traditional | Vascular Graft Solutions, Ltd. | 02/17/2021SE |
| K203803 | VASOBand Vascular Compression DeviceDXC · Traditional | Vasoinnovations, Inc. | 01/26/2021SE |
| K201695 | Patent Hemostasis Band (PH Band)DXC · Traditional | Medical Ingenuities | 10/30/2020SE |
| K192413 | SiteSeal Femoral Compression DeviceDXC · Traditional | Ensite Vacular, LLC | 03/31/2020SE |
| K191827 | Sunmed Disposable Angio-Closure PadsDXC · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 03/16/2020SE |
| K190351 | Site Seal SVDXC · Traditional | Ensite Vascular | 07/02/2019SE |
| K190318 | VASOBand Vascular Compression DeviceDXC · Traditional | Vasoinnovations, Inc. | 03/14/2019SE |
| K180723 | PreludeSYNC DISTAL Radial Compression SystemDXC · Special | Merit Medical Systems, Inc. | 04/17/2018SE |
| K173563 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | Tz Medical, Inc. | 01/10/2018SE |
| K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmDXC · Traditional | Tricol Biomedical, Inc. | 08/29/2017SE |
| K163693 | IntraClude Intra-Aortic Occlusion DeviceDXC · Special | Edwards Lifesciences, LLC | 01/26/2017SE |
| K162988 | PreludeSYNC Radial Compression DeviceDXC · Traditional | Merit Medical Systems, Inc. | 01/25/2017SE |
| K162027 | TRAcelet Compression DeviceDXC · Traditional | Medtronic Vascular | 10/21/2016SE |
| K161315 | Vein Clamps, Artery ClampsDXC · Special | Aros Surgical Instruments Corporation | 08/18/2016SE |
| K153259 | VasoStat Hemostasis DeviceDXC · Traditional | Forge Medical, Inc. | 01/06/2016SE |
| K152525 | TR BAND Radial Compression DeviceDXC · Traditional | Terumo Medical Corporation | 11/10/2015SE |
| K151363 | Zephyr Vascular Compression DeviceDXC · Traditional | Advanced Vascular Dynamics | 07/31/2015SE |
| K143078 | Bookwalter Gordon Adjustable Compression ElementDXC · Traditional | Symmetry Surgical | 05/14/2015SE |
| K150813 | iTClamp50DXC · Special | Innovative Trauma Care, Inc. | 04/30/2015SE |
| K141685 | CrocDXC · Traditional | Combat Medical Systems, LLC | 01/26/2015SE |
| K142122 | Radar Vascular Compression DeviceDXC · Abbreviated | Advanced Vascular Dynamics | 12/04/2014SE |
| K142359 | Vasc Band hemostatDXC · Traditional | Lepu Medical Technology (Beijing) Co., Ltd. | 10/23/2014SE |
| K140805 | Itclamp 50DXC · Traditional | Innovative Trauma Care, Inc. | 10/09/2014SE |
| K132293 | Syvek Radial BandDXC · Traditional | Marine Polymer Technologies | 07/31/2014SE |
| K133029 | Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceDXC · Traditional | Compression Works, LLC | 12/06/2013SE |
| K132651 | Itclamp 50DXC · Traditional | Innovative Trauma Care, Inc. | 10/28/2013SE |
| K131411 | CosealDXC · Traditional | Jilin Coronado Medical , Ltd. | 09/26/2013SE |
| K132175 | Edwards Lifesciences Intraclude Intra-Aortic CatheterDXC · Traditional | Edwards Lifesciences, LLC | 09/13/2013SE |
| K123571 | Cardio Vision Mics Aortic ClampsDXC · Traditional | Cardiomedical GmbH | 08/01/2013SE |
| K131561 | Sam Junctional TourniquetDXC · Traditional | Sam Medical Products | 07/24/2013SE |
| K130382 | Heartstring III Proximal Seal SystemDXC · Traditional | Boston Scientific Corporation | 06/05/2013SE |
| K123041 | Vasostat Hemostasis DeviceDXC · Traditional | Forge Medical, Inc. | 05/29/2013SE |
| K123551 | Itclamp 50DXC · Traditional | Innovative Trauma Care, Inc. | 05/14/2013SE |
| K123077 | Vascular ClampsDXC · Traditional | Hebumedical GmbH | 05/14/2013SE |
| K130482 | Combat Ready ClampDXC · Traditional | Combat Medical Systems, LLC | 04/29/2013SE |
| K130124 | Catalyst II and IIIDXC · Traditional | Cardiva Medical, Inc. | 03/14/2013SE |
| K123694 | Sam Junctional TourniquetDXC · Traditional | Sam Medical Products | 03/07/2013SE |
| K123194 | Junctional Emergency Treatment Tool Model 30-0088DXC · Traditional | North American Rescue Products, Inc. | 01/03/2013SE |
| K123035 | Seal OneDXC · Traditional | Perouse Medical | 11/28/2012SE |
| K122405 | Air-Band Radial Compression DeviceDXC · Traditional | Datascope Corp., Cardiac Assist Division | 11/09/2012SE |
| K120492 | K2 Medical Vascular ClampsDXC · Traditional | K2 Medical GmbH & Co. KG | 04/30/2012SE |
| K113600 | Im BandDXC · Traditional | Synexmed(Shenzhen)Company Limited | 02/08/2012SE |
| K112662 | Microfrance(R) Wormald Vascular ClampDXC · Traditional | Medtronic Xomed, Inc. | 01/20/2012SE |
| K113182 | Edwards Lifesciences Intraclude Intra-Aortic CatheterDXC · Special | Edwards Lifesciences, LLC | 12/07/2011SE |
| K112384 | Abdominal Tourniquet SystemDXC · Traditional | Compression Works, LLC | 10/18/2011SE |
| K112694 | Edwards Lifesciences Endoclamp Aortic CatheterDXC · Special | Edwards Lifesciences, LLC | 10/14/2011SE |
| K111837 | Radial Artery Compression TourniquetDXC · Traditional | Lepu Medical Technology (Beijing) Co., Ltd. | 09/27/2011SE |
| K110148 | Wexler Vascular Clamp SeriesDXC · Traditional | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 04/19/2011SE |
| K110193 | Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II…DXC · Special | St. Jude Medical Systems AB | 02/24/2011SE |
| K102048 | Atraumatic Vascular ClampsDXC · Traditional | Geomed Medizin-Technik GmbH & Co. KG | 11/09/2010SE |
| K102025 | Combat Ready ClampDXC · Traditional | Combat Medical Systems, LLC | 08/11/2010SE |
| K092503 | Radar Vascular Compression DevicesDXC · Traditional | Advanced Vascular Dynamics | 11/19/2009SE |
| K092544 | Instrumed Vascular ClampsDXC · Traditional | Instrumed International, Inc. | 10/26/2009SE |
| K090286 | Pressuremate Manual Femoral Access Compression DeviceDXC · Traditional | Advanced Vascular Dynamics | 03/23/2009SE |
| K082930 | Cardiva Catalyst III System with Protamine SulfateDXC · Traditional | Cardiva Medical, Inc. | 02/13/2009SE |
| K080206 | Modification to Femostop Femoral Compression SystemDXC · Special | Radi Medical Systems AB | 02/26/2008SE |
| K080169 | Heartstring III Proximal Seal SystemDXC · Traditional | Guidant Corporation, Cardiac Surgery | 02/08/2008SE |
| K072834 | Sibel SA Vascular ClampDXC · Traditional | Surgical Instruments Belgium SA | 01/09/2008SE |
| K072297 | Boomerang Catalyst/Boomerang Catalyst II SystemDXC · Special | Cardiva Medical, Inc. | 09/12/2007SE |
| K072167 | Comfortpress Vascular Compression Assist DeviceDXC · Special | Advanced Vascular Dynamics | 09/06/2007SE |
| K071225 | Innovasa Stat*Seal Topical HemostatDXC · Traditional | Innovasa, Inc. | 08/31/2007SE |
| K070661 | Vitalcor Featherweight Vascular ClampsDXC · Traditional | Vitalcor, Inc. | 08/29/2007SE |
| K070380 | Portaclamp FlexDXC · Traditional | Cardio Life Research, S.A. | 06/08/2007SE |
| K070423 | TR BandDXC · Traditional | Terumo Medical Corp. | 03/28/2007SE |
| K070485 | Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LDXC · Special | Cardiva Medical, Inc. | 03/22/2007SE |
| K063871 | D-Stat Handle, Model 8500-053DXC · Traditional | Vascular Solutions, Inc. | 02/28/2007SE |
| K070323 | Temporary Limb Salvage ShuntDXC · Traditional | Vascutek, Ltd. | 02/15/2007SE |
| K062569 | Safeguard 24 CM Pressure Assisted DressingDXC · Abbreviated | Datascope Corp. | 02/14/2007SE |
| K061484 | Modification to: Smithwick Carotid ShuntDXC · Special | Mcpherson Enterprises, Inc. | 12/07/2006SE |
| K051817 | Boomerang Closurewire Vascular Closure SystemDXC · Traditional | Cardiva Medical, Inc. | 12/06/2006SE |
| K062474 | Smithwick Carotid ShuntDXC · Traditional | Mcpherson Enterprises, Inc. | 11/09/2006SE |
| K061075 | Boomerang WireDXC · Special | Cardiva Medical, Inc. | 09/01/2006SE |
| K053300 | SyvekexcelDXC · Traditional | Marine Polymer Technologies, Inc. | 03/28/2006SE |
| K053398 | Compass Compression Assist HandleDXC · Traditional | Semler Technologies, Inc. Dba | 03/10/2006SE |
| K050146 | Vascular Solutions D-Stat Clamp AccessoryDXC · Traditional | Vascular Solutions, Inc. | 05/27/2005SE |
| K041486 | Vasostasis Vascular Closure SystemDXC · Traditional | Cardiva Medical, Inc. | 10/22/2004SE |
| K040730 | Vascular Solutions D-Stat Clamp Hemostatic ClampDXC · Traditional | Vascular Solutions, Inc. | 06/18/2004SE |
| K040615 | Compressar Supercomfort Disc and Strongarm Supercomfort SystemDXC · Special | Advanced Vascular Dynamics | 06/01/2004SE |
| K033085 | PortaclampDXC · Traditional | Cardio Life Research, S.A. | 04/27/2004SE |
| K032125 | Cstat, Models 09-0014-01 and 09-0014-02DXC · Traditional | Vascular Control Systems, Inc. | 02/09/2004SE |
| K031812 | Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03DXC · Traditional | Vascular Control Systems, Inc. | 12/12/2003SE |
| K032589 | Enclose II Anastomosis Assist DeviceDXC · Special | Novare Surgical Systems, Inc. | 09/05/2003SE |
| K023682 | Enclose Anastomosis Assist DeviceDXC · Traditional | Novare Surgical Systems, Inc. | 01/16/2003SE |
| K024107 | Femostop Femoral Compression SystemDXC · Special | Radi Medical Systems AB | 12/24/2002SE |
| K023154 | Vcs-A Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02DXC · Traditional | Vascular Control Systems, Inc. | 12/20/2002SE |
| K014277 | Ksea Deployable Cardiovascular ClampDXC · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/11/2002SE |
| K021608 | Smithwick Carotid ShuntDXC · Traditional | Implantable Devices | 10/22/2002SE |
| K022754 | S&T Single Use Micro Anastomosis ClampDXC · Traditional | S & T AG | 10/16/2002SE |
| K011208 | BioverDXC · Traditional | Biover AG | 10/02/2002SE |
| K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500DXC · Traditional | Guidant Corp. | 09/13/2002SE |
| K010727 | Flexline ClampDXC · Traditional | Novare Surgical Systems, Inc. | 08/09/2002SE |
| K012041 | The Hammer Model H100DXC · Traditional | Tenacore Holdings, Inc. | 03/28/2002SE |
| K011863 | Vcs-A Series ClampDXC · Traditional | Vascular Control Systems, Inc. | 02/15/2002SE |
| K010694 | Includer ClampDXC · Traditional | Novare Surgical Systems, Inc. | 02/11/2002SE |
| K010785 | Ksea Dion-Gracia SetDXC · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/21/2001SE |
| K011078 | Malleable Shaft ClampDXC · Special | Allegiance Healthcare Corp. | 07/13/2001SE |
| K010117 | Guidant Axius Coronary ShuntDXC · Traditional | Cardiothoracic Systems, Inc. | 04/04/2001SE |
| K002915 | Flexible Occlusion SystemDXC · Traditional | Applied Medical | 01/08/2001SE |
| K002767 | Compressar Femoral Access Compression DeviceDXC · Special | Semler Technologies, Inc. | 09/27/2000SE |
| K992980 | Engage Jaw InsertsDXC · Traditional | Novare Surgical Systems, Inc. | 06/08/2000SE |
| K000098 | Softline Spring ClipDXC · Traditional | Novare Surgical Systems, Inc. | 04/12/2000SE |
| K992174 | Pilling Weck Surgical Aortic Spoon-Jaw ClampDXC · Traditional | Pilling Weck Surgical | 03/23/2000SE |
| K992053 | Aesculap Vascular InstrumentsDXC · Traditional | Aesculap, Inc. | 01/13/2000SE |
| K992640 | Slimline Surgical Clamp; Slimline Jaw InsertsDXC · Traditional | Minumys Surgical, Inc. | 09/08/1999SE |
| K984214 | Cordis Endovascular Temporary Occlusion Balloon CatheterDXC · Traditional | Cordis Neurovascular, Inc. | 08/10/1999SE |
| K991589 | Flexible Vascular Clamp, Version 2DXC · Special | Allegiance Healthcare Corp. | 05/18/1999SE |
| K982365 | Atraumatic Vascular Clamps, Model #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX Micro Vascular…DXC · Traditional | Geister Medizin Technik GmbH | 04/08/1999SE |
| K982278 | Micrins Micro Anastomosis ClampDXC · Traditional | Micrins Surgical, Inc. | 03/26/1999SE |
| K990573 | Estech Arterial Remote Access Perfusion CannulaDXC · Traditional | Estech, Inc. | 03/11/1999SE |
| K983471 | Femostop Compression Arch, Femostop Pump, Femostop Bilateral AdapterDXC · Traditional | Radi Medical Systems AB | 02/23/1999SE |
| K980631 | Embol-X Aortic Occlusion and Cardioplegia CannulaDXC · Traditional | Embol-X, Inc. | 02/02/1999SE |
| K982182 | Femostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch Model…DXC · Traditional | Radi Medical Systems AB | 09/18/1998SE |
| K972689 | Caow Hemostasis SystemDXC · Traditional | Anlam Corp. | 08/27/1998SE |
| K981624 | Flo-ThruDXC · Traditional | Bio-Vascular, Inc. | 08/04/1998SE |
| K980128 | Baladi Inverter with Coaxial Aortic PunchDXC · Traditional | Cardio Medical Solutions, Inc. | 07/24/1998SE |
| K981956 | Degania Silicone Identi LoopsDXC · Traditional | Degania Silicone , Ltd. | 07/09/1998SE |
| K980087 | Presdure Products Pressure Pads, Models P100, P110, P120, P130, P200, P210, P220, P230…DXC · Traditional | Pressure Products, Inc. | 07/01/1998SE |
| K980002 | Koala Vascular Clamps and InsertsDXC · Traditional | Boss Instruments, Ltd. | 06/18/1998SE |
| K974769 | Cosgrove ClampDXC · Traditional | Allegiance Healthcare Corp. | 06/12/1998SE |
| K980898 | Femostop II Disposable Set, Femostop II Compression Arch, Femostop II Pump, Femostop II…DXC · Traditional | Radi Medical Systems AB | 04/21/1998SE |
| K973080 | Surgical Vascular ClampDXC · Traditional | Walter Lorenz Surgical, Inc. | 02/23/1998SE |
| K973132 | Ez Hold 1 Lbs., Ez Hold 2 LBSDXC · Traditional | Tz Medical, Inc. | 01/12/1998SE |
| K964663 | Favp: Femoral Artery Vascular Pad - Model Number PAD2EK-01, PAD2EK-2X, PAD5EK-R…DXC · Traditional | Rmds, Inc. | 12/11/1997SE |
| K973216 | Favc-Hh: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T)DXC · Traditional | Rmds, Inc. | 11/25/1997SE |
| K970638 | CTS Midcab Fixedn Diameter Coronary ShuntDXC · Traditional | Cardiothoracic Systems, Inc. | 10/30/1997SE |
| K970611 | Origin Cardiac Stablizer OccluderDXC · Traditional | Origin Medsystems, Inc. | 08/19/1997SE |
| K970027 | Favc-M: Femoral Artery Vascular Clamp-Mobile (Model M100-M200) Favc-M Femoral Artery…DXC · Traditional | Rmds, Inc. | 08/08/1997SE |
| K964251 | Occlusion Clamp** DeviceDXC · Traditional | United States Surgical, A Division of Tyco Healthc | 05/23/1997SE |
| K964161 | Heartport Endoaortic ClampDXC · Traditional | Heartport, Inc. | 04/04/1997SE |
| K963503 | CTS Midcab Coronary ShuntDXC · Traditional | Cardiothoracic Systems, Inc. | 04/03/1997SE |
| K963716 | Mics Device SystemDXC · Traditional | Percutaneous Technologies, Inc. | 04/02/1997SE |
| K964662 | Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS…DXC · Traditional | Rmds, Inc. | 02/03/1997SE |
| K964547 | Degania Silicone Indenti LoopsDXC · Traditional | Degania Silicone , Ltd. | 01/08/1997SE |
| K962366 | Heartport Cable Bulldog ClampDXC · Traditional | Heartport, Inc. | 11/07/1996SE |
| K962668 | Amr-Acv ClampsDXC · Traditional | Applied Medical Resources | 11/04/1996SE |
| K955827 | Daneshvar Wound Support UnitDXC · Traditional | Y. Daneshvar | 10/02/1996SE |
| K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number…DXC · Traditional | Heartport, Inc. | 09/30/1996SE |
| K962510 | Heartport Endoaortic ClampDXC · Traditional | Heartport, Inc. | 09/11/1996SE |
| K955742 | D. Device IIDXC · Traditional | Yousef Daneshvar | 08/12/1996SE |
| K955270 | Tape & Bandage, AdhesiveDXC · Traditional | Robert R. Stevens | 08/08/1996SE |
| K961461 | Daneshvar's Device (Modification)DXC · Traditional | Y. Daneshvar | 06/26/1996SE |
| K961100 | Micro Anastomosis ClampDXC · Traditional | R.S.P. Medical Management, Inc. | 06/19/1996SE |
| K955132 | Heartport Endoaortic ClampDXC · Traditional | Heartport, Inc. | 06/07/1996SE |
| K954669 | Femostop, Femostop PumpDXC · Traditional | Radi Medical Systems AB | 10/27/1995SE |
| K951413 | Fogarty-Hydragrip Surgical ClampsDXC · Traditional | Baxter Healthcare Corp | 08/18/1995SE |
| K944259 | Femostop IIDXC · Traditional | Radi Medical Systems AB | 07/20/1995SE |
| K943948 | Protective ShortsDXC · Traditional | Y. Daneshvar, M.D. | 06/05/1995SE |
| K950492 | Atraumax Surgical ClampDXC · Traditional | Applied Medical Resources | 05/08/1995SE |
| K935964 | Ideas OccluderDXC · Traditional | Ideas For Medicine, Inc. | 01/04/1995SE |
| K935494 | Daneshvar's DeviceDXC · Traditional | Y. Daneshvar | 11/22/1994SE |
| K942812 | Flo-Rester Disposable Vessel OccluderDXC · Traditional | Bio-Vascular, Inc. | 08/01/1994SE |
| K925809 | Compressar Universal (TM) SystemDXC · Traditional | Instromedix, Inc. | 02/22/1993SE |
| K923085 | Quicklamp SystemDXC · Traditional | Disco, Inc. | 02/12/1993SE |
| K920936 | Rmi External Coronary Artery OccluderDXC · Traditional | Research Medical, Inc. | 12/18/1992SE |
| K921399 | Occlusion Ballon Catheter ModificaionDXC · Traditional | Interventional Therapeutics Corp. | 09/25/1992SE |
| K920501 | Silclamps Degania SiliconeDXC · Traditional | Puritas Health Care, Inc. | 06/02/1992SE |
| K915280 | FemostopDXC · Traditional | Radi Medical Systems AB | 04/22/1992SE |
| K914149 | Femoral Artery Pressure Pad/DiskDXC · Traditional | Disco, Inc. | 12/13/1991SE |
| K910221 | Rmi Vascular Tourniquet KitDXC · Traditional | Research Medical, Inc. | 05/16/1991SE |
| K901628 | Applied Vascular Devices 6MM Traction ClipDXC · Traditional | Applied Vascular Devices, Inc. | 07/06/1990SE |
| K901565 | Atraumax Surgical Clamp Model FOG-5048, 75MM SideDXC · Traditional | Applied Vascular Devices, Inc. | 06/12/1990SE |
| K897075 | Pti Intra-Art(Tm) Ansari Saphenous Vein HolderDXC · Traditional | Pioneering Technologies, Inc. | 04/10/1990SE |
| K885161 | Voss Vein ClampDXC · Traditional | Voss Medical Products | 12/22/1989SE |
| K895691 | Vascular ClampDXC · Traditional | Applied Vascular Devices, Inc. | 12/13/1989SE |
| K894670 | General Surgical InstrumentsDXC · Traditional | Nopa Instruments | 08/10/1989SE |
| K891296 | Atraumax(Tm) Surgical ClampsDXC · Traditional | Applied Vascular Devices, Inc. | 06/07/1989SE |
| K883790 | Surgical Clamp InsertsDXC · Traditional | Applied Vascular Devices, Inc. | 12/27/1988SE |
| K883696 | Flo-ResterDXC · Traditional | Bio-Vascular, Inc. | 11/30/1988SE |
| K882879 | Pti Intra-Art(Tm) Coronary Artery Occluders (Ster)DXC · Traditional | Pioneering Technologies, Inc. | 09/12/1988SE |
| K881448 | #557 Disposable Cardiovascular ClampDXC · Traditional | Alpha Industries, Inc. | 06/30/1988SE |
| K881447 | Metatech Metal MicroclipDXC · Traditional | Metatech Corp. | 06/22/1988SE |
| K881158 | Vascular ClampDXC · Traditional | T. Korossurgical Instruments Corp. | 06/20/1988SE |
| K875090 | Auto Suture Disposable Approximating Clamp*DXC · Traditional | United States Surgical, A Division of Tyco Healthc | 02/29/1988SE |
| K863427 | Clampease FaDXC · Traditional | Freund Medical Products | 11/20/1986SE |
| K861924 | Micro Anastomosis ClampDXC · Traditional | Pilling Co. | 06/06/1986SE |
| K851739 | Dunn Vessel Occluder-SterileDXC · Traditional | Richard J. Turner Assoc. | 09/27/1985SE |
| K852479 | Pulmonary Vein ClampDXC · Traditional | None | 08/09/1985SE |
| K831809 | Fogarty Occluder PadDXC · Traditional | Thomas J. Fogarty, M.D. | 08/27/1984SE |
| K832554 | Fogarty 6MM Softjaw ClipDXC · Traditional | American Edwards Laboratories | 09/29/1983SE |
| K820949 | P-S Berlin Vessel ClampDXC · Traditional | Pudenz-Schulte Medical Research Corp. | 04/29/1982SE |
| K813499 | Omed Disposable BulldogDXC · Traditional | Omega-Med Intl., Inc. | 12/29/1981SE |
| K813062 | Vascular PawsDXC · Traditional | Sil-Med Corp. | 12/14/1981SE |
| K810162 | Fogarty Softjaw 6MM Spring Clip, #614-06DXC · Traditional | American Edwards Laboratories | 02/04/1981SE |
| K802244 | Vessel Retractor, #600732DXC · Traditional | Bentley Laboratories, Inc. | 10/03/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2588-2025 Class II | Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the… | Maquet Cardiovascular, LLC | 08/15/2025Open, Classified |
| Z-2587-2025 Class II | Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the… | Maquet Cardiovascular, LLC | 08/15/2025Open, Classified |
| Z-2586-2025 Class II | Heartstring III Proximal Seal System. Intravascular anastomosis occluder.Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the… | Maquet Cardiovascular, LLC | 08/15/2025Open, Classified |
| Z-2637-2025 Class II | JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT…Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential… | North American Rescue LLC. | 07/01/2025Open, Classified |
| Z-1524-2024 Class II | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers:…The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable… | Baxter Healthcare Corporation | 02/22/2024Open, Classified |
| Z-1523-2024 Class II | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers:…The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable… | Baxter Healthcare Corporation | 02/22/2024Open, Classified |
| Z-1522-2024 Class II | Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers:…The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable… | Baxter Healthcare Corporation | 02/22/2024Open, Classified |
| Z-0663-2024 Class II | Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… | Baxter Healthcare Corporation | 12/06/2023Open, Classified |
| Z-0656-2024 Class II | Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… | Baxter Healthcare Corporation | 12/06/2023Open, Classified |
| Z-1019-2022 Class II | Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures.…There is a potential for foreign matter. | Baxter Healthcare Corporation | 04/01/2022Terminated |
| Z-1796-2020 Class II | PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RTDuring the sterilization of radial compression devices, some of the inflatable balloons may break or burst… | Merit Medical Systems, Inc. | 03/11/2020Terminated |
| Z-2435-2019 Class II | Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures…A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an… | Integra LifeSciences Corp. | 08/07/2019Terminated |
| Z-1705-2019 Class I | IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100…Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during… | Edwards Lifesciences, LLC | 05/14/2019Terminated |
| Z-1100-2019 Class II | Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr…Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between… | Edwards Lifesciences, LLC | 01/16/2019Open, Classified |
| Z-1929-2018 Class II | Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile…Possible leak at distal open end of the strain relief, which causes medical staff to continue adding… | Edwards Lifesciences, LLC | 03/30/2018Terminated |
| Z-1766-2017 Class II | The PreludeSYNC Radial Compression Device is a sterile, single use disposable device…Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device… | Merit Medical Systems, Inc. | 03/03/2017Terminated |
| Z-1758-2015 Class II | Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5…Potential device damage on the strain relief near the hub area, which may result in blood leakage. | Edwards Lifesciences, LLC | 05/05/2015Terminated |
| Z-0133-2015 Class II | SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models…SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap… | Sam Medical Products | 08/14/2014Terminated |
| Z-3006-2011 | Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx Surgical Clamps and…The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers:… | Applied Medical Resources Corp | 03/07/2011Terminated |
| Z-3005-2011 | Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and…The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers:… | Applied Medical Resources Corp | 03/07/2011Terminated |
| Z-3004-2011 | Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps…The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers:… | Applied Medical Resources Corp | 03/07/2011Terminated |
| Z-0940-2011 | Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet…Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to… | Maquet Cardiovascular, LLC | 05/05/2010Terminated |
| Z-0085-2010 | EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic…Spontaneous balloon rupture during use of the product. | Edwards Lifesciences Research Medical, Inc. | 09/24/2009Terminated |
| Z-0084-2010 | EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic…Balloon catheters were spontaneously rupturing during use. | Edwards Lifesciences Research Medical, Inc. | 09/24/2009Terminated |
| Z-0645-2009 | CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm…Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further… | Edwards Lifesciences Research Medical, Inc. | 11/26/2008Terminated |
| Z-0644-2009 | Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001…Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further… | Edwards Lifesciences Research Medical, Inc. | 11/26/2008Terminated |