FDA 510(k) Applications for Medical Device Product Code "DXC"
(Clamp, Vascular)

FDA 510(k) Number Applicant Device Name Decision Date
K772137 A&A ENT. VEIN CLAMPS 11/21/1977
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
K881448 ALPHA INDUSTRIES, INC. #557 DISPOSABLE CARDIOVASCULAR CLAMP 06/30/1988
K832554 AMERICAN EDWARDS LABORATORIES FOGARTY 6MM SOFTJAW CLIP 09/29/1983
K810162 AMERICAN EDWARDS LABORATORIES FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06 02/04/1981
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
K950492 APPLIED MEDICAL RESOURCES ATRAUMAX SURGICAL CLAMP 05/08/1995
K901628 APPLIED VASCULAR DEVICES, INC. APPLIED VASCULAR DEVICES 6MM TRACTION CLIP 07/06/1990
K901565 APPLIED VASCULAR DEVICES, INC. ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE 06/12/1990
K891296 APPLIED VASCULAR DEVICES, INC. ATRAUMAX(TM) SURGICAL CLAMPS 06/07/1989
K883790 APPLIED VASCULAR DEVICES, INC. SURGICAL CLAMP INSERTS 12/27/1988
K895691 APPLIED VASCULAR DEVICES, INC. VASCULAR CLAMP 12/13/1989
K161315 AROS Surgical Instruments Corporation Vein Clamps, Artery Clamps 08/18/2016
K951413 BAXTER HEALTHCARE CORP. FOGARTY-HYDRAGRIP SURGICAL CLAMPS 08/18/1995
K802244 BENTLEY LABORATORIES, INC. VESSEL RETRACTOR, #600732 10/03/1980
K883696 BIO-VASCULAR, INC. FLO-RESTER 11/30/1988
K942812 BIO-VASCULAR, INC. FLO-RESTER DISPOSABLE VESSEL OCCLUDER 08/01/1994
K981624 BIO-VASCULAR, INC. FLO-THRU 08/04/1998
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
K130482 COMBAT MEDICAL SYSTEMS, LLC COMBAT READY CLAMP 04/29/2013
K102025 COMBAT MEDICAL SYSTEMS, LLC COMBAT READY CLAMP 08/11/2010
K141685 COMBAT MEDICAL SYSTEMS, LLC CROC 01/26/2015
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
K914149 DISCO, INC. FEMORAL ARTERY PRESSURE PAD/DISK 12/13/1991
K923085 DISCO, INC. QUICKLAMP SYSTEM 02/12/1993
K770503 EDWARD WECK, INC. LOUISVILLE CLAMP PRODUCT #65-172 03/30/1977
K163693 Edwards Lifesciences LLC IntraClude Intra-Aortic Occlusion Device 01/26/2017
K112694 EDWARDS LIFESCIENCES, LLC. EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER 10/14/2011
K132175 EDWARDS LIFESCIENCES, LLC. EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER 09/13/2013
K113182 EDWARDS LIFESCIENCES, LLC. EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER 12/07/2011
K980631 EMBOL-X, INC. EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA 02/02/1999
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
K863427 FREUND MEDICAL PRODUCTS CLAMPEASE FA 11/20/1986
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
K935964 IDEAS FOR MEDICINE, INC. IDEAS OCCLUDER 01/04/1995
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
K925809 INSTROMEDIX, INC. COMPRESSAR UNIVERSAL (TM) SYSTEM 02/22/1993
K092544 INSTRUMED INTERNATIONAL, INC. INSTRUMED VASCULAR CLAMPS 10/26/2009
K921399 INTERVENTIONAL THERAPEUTICS CORP. OCCLUSION BALLON CATHETER MODIFICAION 09/25/1992
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
K791098 MED GENERAL SINGLE-USE MINI-BULLDOG 06/22/1979
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
K881447 METATECH CORP. METATECH METAL MICROCLIP 06/22/1988
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
K852479 NONE PULMONARY VEIN CLAMP 08/09/1985
K894670 NOPA INSTRUMENTS GENERAL SURGICAL INSTRUMENTS 08/10/1989
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
K813499 OMEGA-MED INTL., INC. OMED DISPOSABLE BULLDOG 12/29/1981
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
K761169 PILLING CO. GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP 12/09/1976
K861924 PILLING CO. MICRO ANASTOMOSIS CLAMP 06/06/1986
K992174 PILLING WECK SURGICAL PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP 03/23/2000
K897075 PIONEERING TECHNOLOGIES, INC. PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER 04/10/1990
K882879 PIONEERING TECHNOLOGIES, INC. PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) 09/12/1988
K980087 PRESSURE PRODUCTS, INC. PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 07/01/1998
K820949 PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P-S BERLIN VESSEL CLAMP 04/29/1982
K920501 PURITAS HEALTH CARE, INC. SILCLAMPS DEGANIA SILICONE 06/02/1992
K961100 R.S.P. MEDICAL MANAGEMENT, INC. MICRO ANASTOMOSIS CLAMP 06/19/1996
K915280 RADI MEDICAL SYSTEMS AB FEMOSTOP 04/22/1992
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
K944259 RADI MEDICAL SYSTEMS AB FEMOSTOP II 07/20/1995
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
K954669 RADI MEDICAL SYSTEMS AB FEMOSTOP, FEMOSTOP PUMP 10/27/1995
K080206 RADI MEDICAL SYSTEMS AB MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM 02/26/2008
K920936 RESEARCH MEDICAL, INC. RMI EXTERNAL CORONARY ARTERY OCCLUDER 12/18/1992
K910221 RESEARCH MEDICAL, INC. RMI VASCULAR TOURNIQUET KIT 05/16/1991
K851739 RICHARD J. TURNER ASSOC. DUNN VESSEL OCCLUDER-STERILE 09/27/1985
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
K813062 SIL-MED CORP. VASCULAR PAWS 12/14/1981
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
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
K881158 T. KOROS SURGICAL INSTRUMENTS CORP. VASCULAR CLAMP 06/20/1988
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
K801395 TEXAS MEDICAL PRODUCTS, INC. VASCULAR CLAMP 06/30/1980
K831809 THOMAS J. FOGARTY, M.D. FOGARTY OCCLUDER PAD 08/27/1984
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
K875090 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP* 02/29/1988
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
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
K070661 VITALCOR, INC. VITALCOR FEATHERWEIGHT VASCULAR CLAMPS 08/29/2007
K885161 VOSS MEDICAL PRODUCTS VOSS VEIN CLAMP 12/22/1989
K973080 WALTER LORENZ SURGICAL, INC. SURGICAL VASCULAR CLAMP 02/23/1998
K955827 Y. DANESHVAR DANESHVAR WOUND SUPPORT UNIT 10/02/1996
K935494 Y. DANESHVAR DANESHVAR'S DEVICE 11/22/1994
K961461 Y. DANESHVAR DANESHVAR'S DEVICE (MODIFICATION) 06/26/1996
K943948 Y. DANESHVAR, M.D. PROTECTIVE SHORTS 06/05/1995
K955742 YOUSEF DANESHVAR D. DEVICE II 08/12/1996


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact