Clamp, Vascular
The Vascular Clamp is a cardiovascular surgical instrument used to temporarily occlude blood flow through a vessel segment during vascular repair, anastomosis, or other surgical interventions, allowing the surgeon to operate in a bloodless field. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXC and it is regulated under 21 CFR 870.4450 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DXC
- Device Class
- FDA class 2
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 204 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Jun 05, 2026 | Substantially Equivalent | Edwards Lifesciences |
| K252772 | Arc Adjustable Radial Cuff Compression Device | May 22, 2026 | Substantially Equivalent | Tz Medical, Inc. |
| K254060 | Life Saving Tourniquet | Apr 03, 2026 | Substantially Equivalent | TW Medical |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Dec 31, 2025 | Substantially Equivalent | Arc Trauma, LLC |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Nov 20, 2025 | Substantially Equivalent | Medline Industries, LP |
| K232577 | Radial Compression Device | Jan 18, 2024 | Substantially Equivalent | Ningbo Dizegens Medical Science Co.,Ltd |
| K230281 | PICOCLAMP | Oct 23, 2023 | Substantially Equivalent | Kono Seisakusho Co., Ltd. |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Mar 03, 2023 | Substantially Equivalent | Compression Works, Inc. |
| K230248 | VIOLA | Feb 28, 2023 | Substantially Equivalent | Vascular Graft Solutions, Ltd. |
| K222182 | Radial Artery Compression Tourniquets | Jan 04, 2023 | Substantially Equivalent | Beijing Demax Medical Technology Co.,Ltd |
| K221843 | GEM Biover Microvascular Clamps | Sep 14, 2022 | Substantially Equivalent | Synovis Micro Companies Alliance, Inc. |
| K213531 | TR BAND Radial Compression Device | Dec 20, 2021 | Substantially Equivalent | Terumo Medical Corporation |
| K210681 | SiteSeal SV | Apr 06, 2021 | Substantially Equivalent | Ensite Vascular |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | Mar 04, 2021 | Substantially Equivalent | Carefusion 2200, Inc. |
| K210006 | MI DeTACH | Mar 04, 2021 | Substantially Equivalent | Biorep Technologies, Inc. |
| K203307 | VIOLA | Feb 17, 2021 | Substantially Equivalent | Vascular Graft Solutions, Ltd. |
| K203803 | VASOBand Vascular Compression Device | Jan 26, 2021 | Substantially Equivalent | Vasoinnovations, Inc. |
| K201695 | Patent Hemostasis Band (PH Band) | Oct 30, 2020 | Substantially Equivalent | Medical Ingenuities |
| K192413 | SiteSeal Femoral Compression Device | Mar 31, 2020 | Substantially Equivalent | Ensite Vacular, LLC |
| K191827 | Sunmed Disposable Angio-Closure Pads | Mar 16, 2020 | Substantially Equivalent | Sunny Medical Device (Shenzhen) Co., Ltd. |
| K190351 | Site Seal SV | Jul 02, 2019 | Substantially Equivalent | Ensite Vascular |
| K190318 | VASOBand Vascular Compression Device | Mar 14, 2019 | Substantially Equivalent | Vasoinnovations, Inc. |
| K180723 | PreludeSYNC DISTAL Radial Compression System | Apr 17, 2018 | Substantially Equivalent | Merit Medical Systems, Inc. |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | Jan 10, 2018 | Substantially Equivalent | Tz Medical, Inc. |
| K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | Aug 29, 2017 | Substantially Equivalent | Tricol Biomedical, Inc. |
| K163693 | IntraClude Intra-Aortic Occlusion Device | Jan 26, 2017 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K162988 | PreludeSYNC Radial Compression Device | Jan 25, 2017 | Substantially Equivalent | Merit Medical Systems, Inc. |
| K162027 | TRAcelet Compression Device | Oct 21, 2016 | Substantially Equivalent | Medtronic Vascular |
| K161315 | Vein Clamps, Artery Clamps | Aug 18, 2016 | Substantially Equivalent | Aros Surgical Instruments Corporation |
| K153259 | VasoStat Hemostasis Device | Jan 06, 2016 | Substantially Equivalent | Forge Medical, Inc. |
| K152525 | TR BAND Radial Compression Device | Nov 10, 2015 | Substantially Equivalent | Terumo Medical Corporation |
| K151363 | Zephyr Vascular Compression Device | Jul 31, 2015 | Substantially Equivalent | Advanced Vascular Dynamics |
| K143078 | Bookwalter Gordon Adjustable Compression Element | May 14, 2015 | Substantially Equivalent | Symmetry Surgical |
| K150813 | iTClamp50 | Apr 30, 2015 | Substantially Equivalent | Innovative Trauma Care, Inc. |
| K141685 | CROC | Jan 26, 2015 | Substantially Equivalent | Combat Medical Systems, LLC |
| K142122 | RADAR VASCULAR COMPRESSION DEVICE | Dec 04, 2014 | Substantially Equivalent | Advanced Vascular Dynamics |
| K142359 | Vasc Band hemostat | Oct 23, 2014 | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. |
| K140805 | ITCLAMP 50 | Oct 09, 2014 | Substantially Equivalent | Innovative Trauma Care, Inc. |
| K132293 | SYVEK RADIAL BAND | Jul 31, 2014 | Substantially Equivalent | Marine Polymer Technologies |
| K133029 | ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE | Dec 06, 2013 | Substantially Equivalent | Compression Works, LLC |
| K132651 | ITCLAMP 50 | Oct 28, 2013 | Substantially Equivalent | Innovative Trauma Care, Inc. |
| K131411 | COSEAL | Sep 26, 2013 | Substantially Equivalent | Jilin Coronado Medical , Ltd. |
| K132175 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | Sep 13, 2013 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K123571 | CARDIO VISION MICS AORTIC CLAMPS | Aug 01, 2013 | Substantially Equivalent | Cardiomedical GmbH |
| K131561 | SAM JUNCTIONAL TOURNIQUET | Jul 24, 2013 | Substantially Equivalent | Sam Medical Products |
| K130382 | HEARTSTRING III PROXIMAL SEAL SYSTEM | Jun 05, 2013 | Substantially Equivalent | Boston Scientific Corporation |
| K123041 | VASOSTAT HEMOSTASIS DEVICE | May 29, 2013 | Substantially Equivalent | Forge Medical, Inc. |
| K123551 | ITCLAMP 50 | May 14, 2013 | Substantially Equivalent | Innovative Trauma Care, Inc. |
| K123077 | VASCULAR CLAMPS | May 14, 2013 | Substantially Equivalent | Hebumedical GmbH |
| K130482 | COMBAT READY CLAMP | Apr 29, 2013 | Substantially Equivalent | Combat Medical Systems, LLC |
| K130124 | CATALYST II AND III | Mar 14, 2013 | Substantially Equivalent | Cardiva Medical, Inc. |
| K123694 | SAM JUNCTIONAL TOURNIQUET | Mar 07, 2013 | Substantially Equivalent | Sam Medical Products |
| K123194 | JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 | Jan 03, 2013 | Substantially Equivalent | North American Rescue Products, Inc. |
| K123035 | SEAL ONE | Nov 28, 2012 | Substantially Equivalent | Perouse Medical |
| K122405 | AIR-BAND RADIAL COMPRESSION DEVICE | Nov 09, 2012 | Substantially Equivalent | Datascope Corp., Cardiac Assist Division |
| K120492 | K2 MEDICAL VASCULAR CLAMPS | Apr 30, 2012 | Substantially Equivalent | K2 Medical GmbH & Co. KG |
| K113600 | IM BAND | Feb 08, 2012 | Substantially Equivalent | Synexmed(Shenzhen)Company Limited |
| K112662 | MICROFRANCE(R) WORMALD VASCULAR CLAMP | Jan 20, 2012 | Substantially Equivalent | Medtronic Xomed, Inc. |
| K113182 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | Dec 07, 2011 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K112384 | ABDOMINAL TOURNIQUET SYSTEM | Oct 18, 2011 | Substantially Equivalent | Compression Works, LLC |
| K112694 | EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER | Oct 14, 2011 | Substantially Equivalent | Edwards Lifesciences, LLC |
| K111837 | RADIAL ARTERY COMPRESSION TOURNIQUET | Sep 27, 2011 | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. |
| K110148 | WEXLER VASCULAR CLAMP SERIES | Apr 19, 2011 | Substantially Equivalent | Microsurgical Laboratories,Inc.Dba Wexler Surgical |
| K110193 | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F | Feb 24, 2011 | Substantially Equivalent | St. Jude Medical Systems AB |
| K102048 | ATRAUMATIC VASCULAR CLAMPS | Nov 09, 2010 | Substantially Equivalent | Geomed Medizin-Technik GmbH & Co. KG |
| K102025 | COMBAT READY CLAMP | Aug 11, 2010 | Substantially Equivalent | Combat Medical Systems, LLC |
| K092503 | RADAR VASCULAR COMPRESSION DEVICES | Nov 19, 2009 | Substantially Equivalent | Advanced Vascular Dynamics |
| K092544 | INSTRUMED VASCULAR CLAMPS | Oct 26, 2009 | Substantially Equivalent | Instrumed International, Inc. |
| K090286 | PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE | Mar 23, 2009 | Substantially Equivalent | Advanced Vascular Dynamics |
| K082930 | CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE | Feb 13, 2009 | Substantially Equivalent | Cardiva Medical, Inc. |
| K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | Feb 26, 2008 | Substantially Equivalent | Radi Medical Systems AB |
| K080169 | HEARTSTRING III PROXIMAL SEAL SYSTEM | Feb 08, 2008 | Substantially Equivalent | Guidant Corporation, Cardiac Surgery |
| K072834 | SIBEL SA VASCULAR CLAMP | Jan 09, 2008 | Substantially Equivalent | Surgical Instruments Belgium SA |
| K072297 | BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM | Sep 12, 2007 | Substantially Equivalent | Cardiva Medical, Inc. |
| K072167 | COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE | Sep 06, 2007 | Substantially Equivalent | Advanced Vascular Dynamics |
| K071225 | INNOVASA STAT*SEAL TOPICAL HEMOSTAT | Aug 31, 2007 | Substantially Equivalent | Innovasa, Inc. |
| K070661 | VITALCOR FEATHERWEIGHT VASCULAR CLAMPS | Aug 29, 2007 | Substantially Equivalent | Vitalcor, Inc. |
| K070380 | PORTACLAMP FLEX | Jun 08, 2007 | Substantially Equivalent | Cardio Life Research, S.A. |
| K070423 | TR BAND | Mar 28, 2007 | Substantially Equivalent | Terumo Medical Corp. |
| K070485 | BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L | Mar 22, 2007 | Substantially Equivalent | Cardiva Medical, Inc. |
| K063871 | D-STAT HANDLE, MODEL 8500-053 | Feb 28, 2007 | Substantially Equivalent | Vascular Solutions, Inc. |
| K070323 | TEMPORARY LIMB SALVAGE SHUNT | Feb 15, 2007 | Substantially Equivalent | Vascutek, Ltd. |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | Feb 14, 2007 | Substantially Equivalent | Datascope Corp. |
| K061484 | MODIFICATION TO: SMITHWICK CAROTID SHUNT | Dec 07, 2006 | Substantially Equivalent | Mcpherson Enterprises, Inc. |
| K051817 | BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM | Dec 06, 2006 | Substantially Equivalent | Cardiva Medical, Inc. |
| K062474 | SMITHWICK CAROTID SHUNT | Nov 09, 2006 | Substantially Equivalent | Mcpherson Enterprises, Inc. |
| K061075 | BOOMERANG WIRE | Sep 01, 2006 | Substantially Equivalent | Cardiva Medical, Inc. |
| K053300 | SYVEKEXCEL | Mar 28, 2006 | Substantially Equivalent | Marine Polymer Technologies, Inc. |
| K053398 | COMPASS COMPRESSION ASSIST HANDLE | Mar 10, 2006 | Substantially Equivalent | Semler Technologies, Inc. Dba |
| K050146 | VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY | May 27, 2005 | Substantially Equivalent | Vascular Solutions, Inc. |
| K041486 | VASOSTASIS VASCULAR CLOSURE SYSTEM | Oct 22, 2004 | Substantially Equivalent | Cardiva Medical, Inc. |
| K040730 | VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP | Jun 18, 2004 | Substantially Equivalent | Vascular Solutions, Inc. |
| K040615 | COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM | Jun 01, 2004 | Substantially Equivalent | Advanced Vascular Dynamics |
| K033085 | PORTACLAMP | Apr 27, 2004 | Substantially Equivalent | Cardio Life Research, S.A. |
| K032125 | CSTAT, MODELS 09-0014-01 AND 09-0014-02 | Feb 09, 2004 | Substantially Equivalent | Vascular Control Systems, Inc. |
| K031812 | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 | Dec 12, 2003 | Substantially Equivalent | Vascular Control Systems, Inc. |
| K032589 | ENCLOSE II ANASTOMOSIS ASSIST DEVICE | Sep 05, 2003 | Substantially Equivalent | Novare Surgical Systems, Inc. |
| K023682 | ENCLOSE ANASTOMOSIS ASSIST DEVICE | Jan 16, 2003 | Substantially Equivalent | Novare Surgical Systems, Inc. |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | Dec 24, 2002 | Substantially Equivalent | Radi Medical Systems AB |
| K023154 | VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 | Dec 20, 2002 | Substantially Equivalent | Vascular Control Systems, Inc. |
| K014277 | KSEA DEPLOYABLE CARDIOVASCULAR CLAMP | Dec 11, 2002 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K021608 | SMITHWICK CAROTID SHUNT | Oct 22, 2002 | Substantially Equivalent | Implantable Devices |
| K022754 | S&T SINGLE USE MICRO ANASTOMOSIS CLAMP | Oct 16, 2002 | Substantially Equivalent | S & T AG |
| K011208 | BIOVER | Oct 02, 2002 | Substantially Equivalent | Biover AG |
| K022880 | GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 | Sep 13, 2002 | Substantially Equivalent | Guidant Corp. |
| K010727 | FLEXLINE CLAMP | Aug 09, 2002 | Substantially Equivalent | Novare Surgical Systems, Inc. |
| K012041 | THE HAMMER MODEL H100 | Mar 28, 2002 | Substantially Equivalent | Tenacore Holdings, Inc. |
| K011863 | VCS-A SERIES CLAMP | Feb 15, 2002 | Substantially Equivalent | Vascular Control Systems, Inc. |
| K010694 | INCLUDER CLAMP | Feb 11, 2002 | Substantially Equivalent | Novare Surgical Systems, Inc. |
| K010785 | KSEA DION-GRACIA SET | Aug 21, 2001 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K011078 | MALLEABLE SHAFT CLAMP | Jul 13, 2001 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K010117 | GUIDANT AXIUS CORONARY SHUNT | Apr 04, 2001 | Substantially Equivalent | Cardiothoracic Systems, Inc. |
| K002915 | FLEXIBLE OCCLUSION SYSTEM | Jan 08, 2001 | Substantially Equivalent | Applied Medical |
| K002767 | COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE | Sep 27, 2000 | Substantially Equivalent | Semler Technologies, Inc. |
| K992980 | ENGAGE JAW INSERTS | Jun 08, 2000 | Substantially Equivalent | Novare Surgical Systems, Inc. |
| K000098 | SOFTLINE SPRING CLIP | Apr 12, 2000 | Substantially Equivalent | Novare Surgical Systems, Inc. |
| K992174 | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP | Mar 23, 2000 | Substantially Equivalent | Pilling Weck Surgical |
| K992053 | AESCULAP VASCULAR INSTRUMENTS | Jan 13, 2000 | Substantially Equivalent | Aesculap, Inc. |
| K992640 | SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS | Sep 08, 1999 | Substantially Equivalent | Minumys Surgical, Inc. |
| K984214 | CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER | Aug 10, 1999 | Substantially Equivalent | Cordis Neurovascular, Inc. |
| K991589 | FLEXIBLE VASCULAR CLAMP, VERSION 2 | May 18, 1999 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K982365 | ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT | Apr 08, 1999 | Substantially Equivalent | Geister Medizin Technik GmbH |
| K982278 | MICRINS MICRO ANASTOMOSIS CLAMP | Mar 26, 1999 | Substantially Equivalent | Micrins Surgical, Inc. |
| K990573 | ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA | Mar 11, 1999 | Substantially Equivalent | Estech, Inc. |
| K983471 | FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER | Feb 23, 1999 | Substantially Equivalent | Radi Medical Systems AB |
| K980631 | EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA | Feb 02, 1999 | Substantially Equivalent | Embol-X, Inc. |
| K982182 | FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 | Sep 18, 1998 | Substantially Equivalent | Radi Medical Systems AB |
| K972689 | CAOW HEMOSTASIS SYSTEM | Aug 27, 1998 | Substantially Equivalent | Anlam Corp. |
| K981624 | FLO-THRU | Aug 04, 1998 | Substantially Equivalent | Bio-Vascular, Inc. |
| K980128 | BALADI INVERTER WITH COAXIAL AORTIC PUNCH | Jul 24, 1998 | Substantially Equivalent | Cardio Medical Solutions, Inc. |
| K981956 | DEGANIA SILICONE IDENTI LOOPS | Jul 09, 1998 | Substantially Equivalent | Degania Silicone , Ltd. |
| K980087 | PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 | Jul 01, 1998 | Substantially Equivalent | Pressure Products, Inc. |
| K980002 | KOALA VASCULAR CLAMPS AND INSERTS | Jun 18, 1998 | Substantially Equivalent | Boss Instruments, Ltd. |
| K974769 | COSGROVE CLAMP | Jun 12, 1998 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K980898 | FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER | Apr 21, 1998 | Substantially Equivalent | Radi Medical Systems AB |
| K973080 | SURGICAL VASCULAR CLAMP | Feb 23, 1998 | Substantially Equivalent | Walter Lorenz Surgical, Inc. |
| K973132 | EZ HOLD 1 LBS., EZ HOLD 2 LBS | Jan 12, 1998 | Substantially Equivalent | Tz Medical, Inc. |
| K964663 | FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX | Dec 11, 1997 | Substantially Equivalent | Rmds, Inc. |
| K973216 | FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) | Nov 25, 1997 | Substantially Equivalent | Rmds, Inc. |
| K970638 | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT | Oct 30, 1997 | Substantially Equivalent | Cardiothoracic Systems, Inc. |
| K970611 | ORIGIN CARDIAC STABLIZER OCCLUDER | Aug 19, 1997 | Substantially Equivalent | Origin Medsystems, Inc. |
| K970027 | FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 | Aug 08, 1997 | Substantially Equivalent | Rmds, Inc. |
| K964251 | OCCLUSION CLAMP** DEVICE | May 23, 1997 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K964161 | HEARTPORT ENDOAORTIC CLAMP | Apr 04, 1997 | Substantially Equivalent | Heartport, Inc. |
| K963503 | CTS MIDCAB CORONARY SHUNT | Apr 03, 1997 | Substantially Equivalent | Cardiothoracic Systems, Inc. |
| K963716 | MICS DEVICE SYSTEM | Apr 02, 1997 | Substantially Equivalent | Percutaneous Technologies, Inc. |
| K964662 | FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 | Feb 03, 1997 | Substantially Equivalent | Rmds, Inc. |
| K964547 | DEGANIA SILICONE INDENTI LOOPS | Jan 08, 1997 | Substantially Equivalent | Degania Silicone , Ltd. |
| K962366 | HEARTPORT CABLE BULLDOG CLAMP | Nov 07, 1996 | Substantially Equivalent | Heartport, Inc. |
| K962668 | AMR-ACV CLAMPS | Nov 04, 1996 | Substantially Equivalent | Applied Medical Resources |
| K955827 | DANESHVAR WOUND SUPPORT UNIT | Oct 02, 1996 | Substantially Equivalent | Y. Daneshvar |
| K962858 | HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM | Sep 30, 1996 | Substantially Equivalent | Heartport, Inc. |
| K962510 | HEARTPORT ENDOAORTIC CLAMP | Sep 11, 1996 | Substantially Equivalent | Heartport, Inc. |
| K955742 | D. DEVICE II | Aug 12, 1996 | Substantially Equivalent | Yousef Daneshvar |
| K955270 | TAPE & BANDAGE, ADHESIVE | Aug 08, 1996 | Substantially Equivalent | Robert R. Stevens |
| K961461 | DANESHVAR'S DEVICE (MODIFICATION) | Jun 26, 1996 | Substantially Equivalent | Y. Daneshvar |
| K961100 | MICRO ANASTOMOSIS CLAMP | Jun 19, 1996 | Substantially Equivalent | R.S.P. Medical Management, Inc. |
| K955132 | HEARTPORT ENDOAORTIC CLAMP | Jun 07, 1996 | Substantially Equivalent | Heartport, Inc. |
| K954669 | FEMOSTOP, FEMOSTOP PUMP | Oct 27, 1995 | Substantially Equivalent | Radi Medical Systems AB |
| K951413 | FOGARTY-HYDRAGRIP SURGICAL CLAMPS | Aug 18, 1995 | Substantially Equivalent | Baxter Healthcare Corp |
| K944259 | FEMOSTOP II | Jul 20, 1995 | Substantially Equivalent | Radi Medical Systems AB |
| K943948 | PROTECTIVE SHORTS | Jun 05, 1995 | Substantially Equivalent | Y. Daneshvar, M.D. |
| K950492 | ATRAUMAX SURGICAL CLAMP | May 08, 1995 | Substantially Equivalent | Applied Medical Resources |
| K935964 | IDEAS OCCLUDER | Jan 04, 1995 | Substantially Equivalent | Ideas For Medicine, Inc. |
| K935494 | DANESHVAR'S DEVICE | Nov 22, 1994 | Substantially Equivalent | Y. Daneshvar |
| K942812 | FLO-RESTER DISPOSABLE VESSEL OCCLUDER | Aug 01, 1994 | Substantially Equivalent | Bio-Vascular, Inc. |
| K925809 | COMPRESSAR UNIVERSAL (TM) SYSTEM | Feb 22, 1993 | Substantially Equivalent | Instromedix, Inc. |
| K923085 | QUICKLAMP SYSTEM | Feb 12, 1993 | Substantially Equivalent | Disco, Inc. |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | Dec 18, 1992 | Substantially Equivalent | Research Medical, Inc. |
| K921399 | OCCLUSION BALLON CATHETER MODIFICAION | Sep 25, 1992 | Substantially Equivalent | Interventional Therapeutics Corp. |
| K920501 | SILCLAMPS DEGANIA SILICONE | Jun 02, 1992 | Substantially Equivalent | Puritas Health Care, Inc. |
| K915280 | FEMOSTOP | Apr 22, 1992 | Substantially Equivalent | Radi Medical Systems AB |
| K914149 | FEMORAL ARTERY PRESSURE PAD/DISK | Dec 13, 1991 | Substantially Equivalent | Disco, Inc. |
| K910221 | RMI VASCULAR TOURNIQUET KIT | May 16, 1991 | Substantially Equivalent | Research Medical, Inc. |
| K901628 | APPLIED VASCULAR DEVICES 6MM TRACTION CLIP | Jul 06, 1990 | Substantially Equivalent | Applied Vascular Devices, Inc. |
| K901565 | ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE | Jun 12, 1990 | Substantially Equivalent | Applied Vascular Devices, Inc. |
| K897075 | PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER | Apr 10, 1990 | Substantially Equivalent | Pioneering Technologies, Inc. |
| K885161 | VOSS VEIN CLAMP | Dec 22, 1989 | Substantially Equivalent | Voss Medical Products |
| K895691 | VASCULAR CLAMP | Dec 13, 1989 | Substantially Equivalent | Applied Vascular Devices, Inc. |
| K894670 | GENERAL SURGICAL INSTRUMENTS | Aug 10, 1989 | Substantially Equivalent | Nopa Instruments |
| K891296 | ATRAUMAX(TM) SURGICAL CLAMPS | Jun 07, 1989 | Substantially Equivalent | Applied Vascular Devices, Inc. |
| K883790 | SURGICAL CLAMP INSERTS | Dec 27, 1988 | Substantially Equivalent | Applied Vascular Devices, Inc. |
| K883696 | FLO-RESTER | Nov 30, 1988 | Substantially Equivalent | Bio-Vascular, Inc. |
| K882879 | PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) | Sep 12, 1988 | Substantially Equivalent | Pioneering Technologies, Inc. |
| K881448 | #557 DISPOSABLE CARDIOVASCULAR CLAMP | Jun 30, 1988 | Substantially Equivalent | Alpha Industries, Inc. |
| K881447 | METATECH METAL MICROCLIP | Jun 22, 1988 | Substantially Equivalent | Metatech Corp. |
| K881158 | VASCULAR CLAMP | Jun 20, 1988 | Substantially Equivalent | T. Korossurgical Instruments Corp. |
| K875090 | AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP* | Feb 29, 1988 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K863427 | CLAMPEASE FA | Nov 20, 1986 | Substantially Equivalent | Freund Medical Products |
| K861924 | MICRO ANASTOMOSIS CLAMP | Jun 06, 1986 | Substantially Equivalent | Pilling Co. |
| K851739 | DUNN VESSEL OCCLUDER-STERILE | Sep 27, 1985 | Substantially Equivalent | Richard J. Turner Assoc. |
| K852479 | PULMONARY VEIN CLAMP | Aug 09, 1985 | Substantially Equivalent | None |
| K831809 | FOGARTY OCCLUDER PAD | Aug 27, 1984 | Substantially Equivalent | Thomas J. Fogarty, M.D. |
| K832554 | FOGARTY 6MM SOFTJAW CLIP | Sep 29, 1983 | Substantially Equivalent | American Edwards Laboratories |
| K820949 | P-S BERLIN VESSEL CLAMP | Apr 29, 1982 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K813499 | OMED DISPOSABLE BULLDOG | Dec 29, 1981 | Substantially Equivalent | Omega-Med Intl., Inc. |
| K813062 | VASCULAR PAWS | Dec 14, 1981 | Substantially Equivalent | Sil-Med Corp. |
| K810162 | FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 | Feb 04, 1981 | Substantially Equivalent | American Edwards Laboratories |
| K802244 | VESSEL RETRACTOR, #600732 | Oct 03, 1980 | Substantially Equivalent | Bentley Laboratories, Inc. |
| K801395 | VASCULAR CLAMP | Jun 30, 1980 | Substantially Equivalent | Texas Medical Products, Inc. |
| K791098 | SINGLE-USE MINI-BULLDOG | Jun 22, 1979 | Substantially Equivalent | Med General |
| K772137 | VEIN CLAMPS | Nov 21, 1977 | Substantially Equivalent | A&A Ent. |
| K770503 | LOUISVILLE CLAMP PRODUCT #65-172 | Mar 30, 1977 | Substantially Equivalent | Edward Weck, Inc. |
| K761169 | GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP | Dec 09, 1976 | Substantially Equivalent | Pilling Co. |
FEI Numbers
This FDA classification entry is associated with 186 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 186 registration numbers. Click on an entry to view related FDA registrations.