FDA 510(k) Applications for Medical Device Product Code "DXC"
(Clamp, Vascular)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K072167 | ADVANCED VASCULAR DYNAMICS | COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE | 09/06/2007 |
| K040615 | ADVANCED VASCULAR DYNAMICS | COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM | 06/01/2004 |
| K090286 | ADVANCED VASCULAR DYNAMICS | PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE | 03/23/2009 |
| K142122 | ADVANCED VASCULAR DYNAMICS | RADAR VASCULAR COMPRESSION DEVICE | 12/04/2014 |
| K092503 | ADVANCED VASCULAR DYNAMICS | RADAR VASCULAR COMPRESSION DEVICES | 11/19/2009 |
| K151363 | ADVANCED VASCULAR DYNAMICS | Zephyr Vascular Compression Device | 07/31/2015 |
| K992053 | AESCULAP, INC. | AESCULAP VASCULAR INSTRUMENTS | 01/13/2000 |
| K974769 | ALLEGIANCE HEALTHCARE CORP. | COSGROVE CLAMP | 06/12/1998 |
| K991589 | ALLEGIANCE HEALTHCARE CORP. | FLEXIBLE VASCULAR CLAMP, VERSION 2 | 05/18/1999 |
| K011078 | ALLEGIANCE HEALTHCARE CORP. | MALLEABLE SHAFT CLAMP | 07/13/2001 |
| K972689 | ANLAM CORP. | CAOW HEMOSTASIS SYSTEM | 08/27/1998 |
| K002915 | APPLIED MEDICAL | FLEXIBLE OCCLUSION SYSTEM | 01/08/2001 |
| K962668 | APPLIED MEDICAL RESOURCES | AMR-ACV CLAMPS | 11/04/1996 |
| K161315 | AROS Surgical Instruments Corporation | Vein Clamps, Artery Clamps | 08/18/2016 |
| K222182 | Beijing Demax Medical Technology Co., Ltd. | Radial Artery Compression Tourniquets | 01/04/2023 |
| K981624 | BIO-VASCULAR, INC. | FLO-THRU | 08/04/1998 |
| K210006 | Biorep Technologies, Inc | MI DeTACH | 03/04/2021 |
| K011208 | BIOVER AG | BIOVER | 10/02/2002 |
| K980002 | BOSS INSTRUMENTS, LTD. | KOALA VASCULAR CLAMPS AND INSERTS | 06/18/1998 |
| K130382 | Boston Scientific Corporation | HEARTSTRING III PROXIMAL SEAL SYSTEM | 06/05/2013 |
| K033085 | CARDIO LIFE RESEARCH, S.A. | PORTACLAMP | 04/27/2004 |
| K070380 | CARDIO LIFE RESEARCH, S.A. | PORTACLAMP FLEX | 06/08/2007 |
| K980128 | CARDIO MEDICAL SOLUTIONS, INC. | BALADI INVERTER WITH COAXIAL AORTIC PUNCH | 07/24/1998 |
| K123571 | CARDIOMEDICAL GMBH | CARDIO VISION MICS AORTIC CLAMPS | 08/01/2013 |
| K963503 | CARDIOTHORACIC SYSTEMS, INC. | CTS MIDCAB CORONARY SHUNT | 04/03/1997 |
| K970638 | CARDIOTHORACIC SYSTEMS, INC. | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT | 10/30/1997 |
| K010117 | CARDIOTHORACIC SYSTEMS, INC. | GUIDANT AXIUS CORONARY SHUNT | 04/04/2001 |
| K072297 | CARDIVA MEDICAL, INC. | BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM | 09/12/2007 |
| K051817 | CARDIVA MEDICAL, INC. | BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM | 12/06/2006 |
| K061075 | CARDIVA MEDICAL, INC. | BOOMERANG WIRE | 09/01/2006 |
| K070485 | CARDIVA MEDICAL, INC. | BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L | 03/22/2007 |
| K082930 | CARDIVA MEDICAL, INC. | CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE | 02/13/2009 |
| K130124 | CARDIVA MEDICAL, INC. | CATALYST II AND III | 03/14/2013 |
| K041486 | CARDIVA MEDICAL, INC. | VASOSTASIS VASCULAR CLOSURE SYSTEM | 10/22/2004 |
| K210324 | CareFusion 2200 Inc | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | 03/04/2021 |
| K102025 | COMBAT MEDICAL SYSTEMS, LLC | COMBAT READY CLAMP | 08/11/2010 |
| K130482 | COMBAT MEDICAL SYSTEMS, LLC | COMBAT READY CLAMP | 04/29/2013 |
| K141685 | COMBAT MEDICAL SYSTEMS, LLC | CROC | 01/26/2015 |
| K221661 | Compression Works Inc | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | 03/03/2023 |
| K112384 | COMPRESSION WORKS LLC | ABDOMINAL TOURNIQUET SYSTEM | 10/18/2011 |
| K133029 | COMPRESSION WORKS, LLC | ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE | 12/06/2013 |
| K984214 | CORDIS NEUROVASCULAR, INC. | CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER | 08/10/1999 |
| K062569 | DATASCOPE CORP. | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | 02/14/2007 |
| K122405 | DATASCOPE CORP., CARDIAC ASSIST DIVISION | AIR-BAND RADIAL COMPRESSION DEVICE | 11/09/2012 |
| K981956 | DEGANIA SILICONE, LTD. | DEGANIA SILICONE IDENTI LOOPS | 07/09/1998 |
| K964547 | DEGANIA SILICONE, LTD. | DEGANIA SILICONE INDENTI LOOPS | 01/08/1997 |
| K163693 | Edwards Lifesciences LLC | IntraClude Intra-Aortic Occlusion Device | 01/26/2017 |
| K112694 | EDWARDS LIFESCIENCES, LLC. | EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER | 10/14/2011 |
| K113182 | EDWARDS LIFESCIENCES, LLC. | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | 12/07/2011 |
| K132175 | EDWARDS LIFESCIENCES, LLC. | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | 09/13/2013 |
| K980631 | EMBOL-X, INC. | EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA | 02/02/1999 |
| K192413 | Ensite Vacular, LLC | SiteSeal Femoral Compression Device | 03/31/2020 |
| K190351 | Ensite Vascular | Site Seal SV | 07/02/2019 |
| K210681 | Ensite Vascular | SiteSeal SV | 04/06/2021 |
| K990573 | ESTECH, INC. | ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA | 03/11/1999 |
| K123041 | FORGE MEDICAL INC. | VASOSTAT HEMOSTASIS DEVICE | 05/29/2013 |
| K153259 | FORGE MEDICAL, INC. | VasoStat Hemostasis Device | 01/06/2016 |
| K982365 | GEISTER MEDIZINTECHNIK GMBH | ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT | 04/08/1999 |
| K102048 | GEOMED MEDIZIN- TECHNIK GMBH & CO. KG | ATRAUMATIC VASCULAR CLAMPS | 11/09/2010 |
| K022880 | GUIDANT CORP. | GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 | 09/13/2002 |
| K080169 | GUIDANT CORPORATION, CARDIAC SURGERY | HEARTSTRING III PROXIMAL SEAL SYSTEM | 02/08/2008 |
| K962366 | HEARTPORT, INC. | HEARTPORT CABLE BULLDOG CLAMP | 11/07/1996 |
| K955132 | HEARTPORT, INC. | HEARTPORT ENDOAORTIC CLAMP | 06/07/1996 |
| K962510 | HEARTPORT, INC. | HEARTPORT ENDOAORTIC CLAMP | 09/11/1996 |
| K964161 | HEARTPORT, INC. | HEARTPORT ENDOAORTIC CLAMP | 04/04/1997 |
| K962858 | HEARTPORT, INC. | HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM | 09/30/1996 |
| K123077 | HEBU MEDICAL GMBH | VASCULAR CLAMPS | 05/14/2013 |
| K021608 | IMPLANTABLE DEVICES | SMITHWICK CAROTID SHUNT | 10/22/2002 |
| K071225 | INNOVASA, INC. | INNOVASA STAT*SEAL TOPICAL HEMOSTAT | 08/31/2007 |
| K123551 | INNOVATIVE TRAUMA CARE INC | ITCLAMP 50 | 05/14/2013 |
| K132651 | INNOVATIVE TRAUMA CARE INC | ITCLAMP 50 | 10/28/2013 |
| K140805 | INNOVATIVE TRAUMA CARE INC | ITCLAMP 50 | 10/09/2014 |
| K150813 | INNOVATIVE TRAUMA CARE INC | iTClamp50 | 04/30/2015 |
| K092544 | INSTRUMED INTERNATIONAL, INC. | INSTRUMED VASCULAR CLAMPS | 10/26/2009 |
| K131411 | JILIN CORONADO MEDICAL LTD. | COSEAL | 09/26/2013 |
| K120492 | K2 MEDICAL GMBH & CO. KG | K2 MEDICAL VASCULAR CLAMPS | 04/30/2012 |
| K014277 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA DEPLOYABLE CARDIOVASCULAR CLAMP | 12/11/2002 |
| K010785 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA DION-GRACIA SET | 08/21/2001 |
| K111837 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | RADIAL ARTERY COMPRESSION TOURNIQUET | 09/27/2011 |
| K142359 | Lepu Medical Technology (Beijing) Co., LTD | Vasc Band hemostat | 10/23/2014 |
| K132293 | MARINE POLYMER TECHNOLOGIES | SYVEK RADIAL BAND | 07/31/2014 |
| K053300 | MARINE POLYMER TECHNOLOGIES, INC. | SYVEKEXCEL | 03/28/2006 |
| K061484 | MCPHERSON ENTERPRISES, INC. | MODIFICATION TO: SMITHWICK CAROTID SHUNT | 12/07/2006 |
| K062474 | MCPHERSON ENTERPRISES, INC. | SMITHWICK CAROTID SHUNT | 11/09/2006 |
| K201695 | Medical Ingenuities | Patent Hemostasis Band (PH Band) | 10/30/2020 |
| K162027 | MEDTRONIC VASCULAR | TRAcelet Compression Device | 10/21/2016 |
| K112662 | MEDTRONIC XOMED, INC. | MICROFRANCE(R) WORMALD VASCULAR CLAMP | 01/20/2012 |
| K180723 | Merit Medical Systems, Inc | PreludeSYNC DISTAL Radial Compression System | 04/17/2018 |
| K162988 | Merit Medical Systems, Inc. | PreludeSYNC Radial Compression Device | 01/25/2017 |
| K982278 | MICRINS SURGICAL, INC. | MICRINS MICRO ANASTOMOSIS CLAMP | 03/26/1999 |
| K110148 | MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL | WEXLER VASCULAR CLAMP SERIES | 04/19/2011 |
| K992640 | MINUMYS SURGICAL, INC. | SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS | 09/08/1999 |
| K123194 | NORTH AMERICAN RESCUE PRODUCTS, INC. | JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 | 01/03/2013 |
| K023682 | NOVARE SURGICAL SYSTEMS, INC. | ENCLOSE ANASTOMOSIS ASSIST DEVICE | 01/16/2003 |
| K032589 | NOVARE SURGICAL SYSTEMS, INC. | ENCLOSE II ANASTOMOSIS ASSIST DEVICE | 09/05/2003 |
| K992980 | NOVARE SURGICAL SYSTEMS, INC. | ENGAGE JAW INSERTS | 06/08/2000 |
| K010727 | NOVARE SURGICAL SYSTEMS, INC. | FLEXLINE CLAMP | 08/09/2002 |
| K010694 | NOVARE SURGICAL SYSTEMS, INC. | INCLUDER CLAMP | 02/11/2002 |
| K000098 | NOVARE SURGICAL SYSTEMS, INC. | SOFTLINE SPRING CLIP | 04/12/2000 |
| K970611 | ORIGIN MEDSYSTEMS, INC. | ORIGIN CARDIAC STABLIZER OCCLUDER | 08/19/1997 |
| K963716 | PERCUTANEOUS TECHNOLOGIES, INC. | MICS DEVICE SYSTEM | 04/02/1997 |
| K123035 | Perouse Medical | SEAL ONE | 11/28/2012 |
| K992174 | PILLING WECK SURGICAL | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP | 03/23/2000 |
| K980087 | PRESSURE PRODUCTS, INC. | PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 | 07/01/1998 |
| K961100 | R.S.P. MEDICAL MANAGEMENT, INC. | MICRO ANASTOMOSIS CLAMP | 06/19/1996 |
| K983471 | RADI MEDICAL SYSTEMS AB | FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER | 02/23/1999 |
| K024107 | RADI MEDICAL SYSTEMS AB | FEMOSTOP FEMORAL COMPRESSION SYSTEM | 12/24/2002 |
| K980898 | RADI MEDICAL SYSTEMS AB | FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER | 04/21/1998 |
| K982182 | RADI MEDICAL SYSTEMS AB | FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 | 09/18/1998 |
| K080206 | RADI MEDICAL SYSTEMS AB | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | 02/26/2008 |
| K973216 | RMDS, INC. | FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) | 11/25/1997 |
| K970027 | RMDS, INC. | FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 | 08/08/1997 |
| K964662 | RMDS, INC. | FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 | 02/03/1997 |
| K964663 | RMDS, INC. | FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX | 12/11/1997 |
| K955270 | ROBERT R. STEVENS | TAPE & BANDAGE, ADHESIVE | 08/08/1996 |
| K022754 | S & T AG | S&T SINGLE USE MICRO ANASTOMOSIS CLAMP | 10/16/2002 |
| K131561 | SAM MEDICAL PRODUCTS | SAM JUNCTIONAL TOURNIQUET | 07/24/2013 |
| K123694 | SAM MEDICAL PRODUCTS | SAM JUNCTIONAL TOURNIQUET | 03/07/2013 |
| K002767 | SEMLER TECHNOLOGIES, INC. | COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE | 09/27/2000 |
| K053398 | SEMLER TECHNOLOGIES, INC. DBA | COMPASS COMPRESSION ASSIST HANDLE | 03/10/2006 |
| K110193 | ST. JUDE MEDICAL SYSTEMS AB | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F | 02/24/2011 |
| K191827 | Sunny Medical Device (Shenzhen) Co.,Ltd. | Sunmed Disposable Angio-Closure Pads | 03/16/2020 |
| K072834 | SURGICAL INSTRUMENTS BELGIUM SA | SIBEL SA VASCULAR CLAMP | 01/09/2008 |
| K143078 | SYMMETRY SURGICAL | Bookwalter Gordon Adjustable Compression Element | 05/14/2015 |
| K113600 | SYNEXMED (SHENZHEN) COMPANY LIMITED | IM BAND | 02/08/2012 |
| K221843 | Synovis Micro Companies Alliance, Inc. | GEM Biover Microvascular Clamps | 09/14/2022 |
| K012041 | TENACORE HOLDINGS, INC. | THE HAMMER MODEL H100 | 03/28/2002 |
| K070423 | TERUMO MEDICAL CORP. | TR BAND | 03/28/2007 |
| K152525 | TERUMO MEDICAL CORPORATION | TR BAND Radial Compression Device | 11/10/2015 |
| K213531 | Terumo Medical Corporation | TR BAND Radial Compression Device | 12/20/2021 |
| K170958 | Tricol Biomedical Inc. | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | 08/29/2017 |
| K173563 | TZ Medical Inc | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | 01/10/2018 |
| K973132 | TZ MEDICAL, INC. | EZ HOLD 1 LBS., EZ HOLD 2 LBS | 01/12/1998 |
| K964251 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC | OCCLUSION CLAMP** DEVICE | 05/23/1997 |
| K032125 | VASCULAR CONTROL SYSTEMS, INC | CSTAT, MODELS 09-0014-01 AND 09-0014-02 | 02/09/2004 |
| K031812 | VASCULAR CONTROL SYSTEMS, INC | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 | 12/12/2003 |
| K011863 | VASCULAR CONTROL SYSTEMS, INC | VCS-A SERIES CLAMP | 02/15/2002 |
| K023154 | VASCULAR CONTROL SYSTEMS, INC | VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 | 12/20/2002 |
| K203307 | Vascular Graft Solutions, Ltd. | VIOLA | 02/17/2021 |
| K230248 | Vascular Graft Solutions, Ltd. | VIOLA | 02/28/2023 |
| K063871 | VASCULAR SOLUTIONS, INC. | D-STAT HANDLE, MODEL 8500-053 | 02/28/2007 |
| K050146 | VASCULAR SOLUTIONS, INC. | VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY | 05/27/2005 |
| K040730 | VASCULAR SOLUTIONS, INC. | VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP | 06/18/2004 |
| K070323 | VASCUTEK LTD. | TEMPORARY LIMB SALVAGE SHUNT | 02/15/2007 |
| K190318 | VASOInnovations Inc. | VASOBand Vascular Compression Device | 03/14/2019 |
| K203803 | VASOInnovations, Inc | VASOBand Vascular Compression Device | 01/26/2021 |
| K070661 | VITALCOR, INC. | VITALCOR FEATHERWEIGHT VASCULAR CLAMPS | 08/29/2007 |
| K973080 | WALTER LORENZ SURGICAL, INC. | SURGICAL VASCULAR CLAMP | 02/23/1998 |
| K955827 | Y. DANESHVAR | DANESHVAR WOUND SUPPORT UNIT | 10/02/1996 |
| K961461 | Y. DANESHVAR | DANESHVAR'S DEVICE (MODIFICATION) | 06/26/1996 |
| K955742 | YOUSEF DANESHVAR | D. DEVICE II | 08/12/1996 |
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