FDA 510(k) Applications for Medical Device Product Code "DWS"
(Instruments, Surgical, Cardiovascular)

FDA 510(k) Number Applicant Device Name Decision Date
K892804 ACACIA LABORATORIES, INC. NEWCHILL(TM) CARDIAC INSULATOR 07/14/1989
K831455 AMERICAN V. MUELLER LEATHER VALVE CUTTER 07/07/1983
K821569 AMERICAN V. MUELLER LEATHER VALVULOTOME 05/27/1982
K896307 BIO-VASCULAR, INC. INSULATION PAD 01/19/1990
K875016 BIOSURGE, INC. BIOSURGE MODEL ILVC-1 02/29/1988
K881717 BUCKMAN CO., INC. PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) 07/05/1988
K894738 CARDIAC PACEMAKERS, INC. MODEL 6888 LEAD TUNNELER 09/13/1989
K934727 CARDIAC PACEMAKERS, INC. REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER 01/10/1994
K823094 CARDIO SURGICAL RESEARCH, INC. CARDIAC ELEVATOR 12/15/1982
K760624 COBE LABORATORIES, INC. SMALL VESSEL CANNULA 09/17/1976
K761161 CODMAN & SHURTLEFF, INC. 67-8006 DARLING-LINTON AORTIC TOURN. 12/06/1976
K771026 CODMAN & SHURTLEFF, INC. HUANG VEIN HOLDER, #21-8011 06/20/1977
K791370 CONPHAR, INC. SILICONE SURGICAL VESSEL LOOPS 08/03/1979
K955689 CONTOUR FABRICATORS OF FLORIDA, INC. RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY 05/15/1996
K851152 CRYOMEDICS, INC. MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR 06/24/1985
K813284 CUNNINGHAM WOODLAND, INC. VENOUS CANNULA TRAY 12/29/1981
K890432 DEKNATEL, INC. DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) 04/13/1989
K964445 DLP, INC. OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) 01/30/1997
K890707 DLP, INC. PHRENIC NERVE PAD & NERVE PAD W/1/4" PERCARDIAL 04/10/1989
K792088 EDWARD WECK, INC. AORTIC OCCLUDER #000390 10/26/1979
K791710 EDWARD WECK, INC. CARDIOVASCULAR INSTRUMENTS-VARIOUS 09/12/1979
K792576 EDWARD WECK, INC. CASTROVIEJO VASCULAR SCISSORS 12/19/1979
K780567 ETHICON, INC. AORTIC PUMP 04/28/1978
K833547 FORMEDCO, INC. ROTARY VASCULAR KNIFE 01/26/1984
K960139 GE MEDICAL SYSTEMS G.E. STERILE ANGIOGRAPHIC TRAY 04/19/1996
K960144 GE MEDICAL SYSTEMS G.E. STERILE CT BIOPSY TRAY 04/15/1996
K960143 GE MEDICAL SYSTEMS G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY 04/09/1996
K800122 HANCOCK LABORATORIES, INC. HANCOCK AORTIC PUNCH 02/01/1980
K820258 HOWMEDICA CORP. DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH 03/02/1982
K802079 HOWMEDICA CORP. DEKNATEL GOOSEN VASCULAR PUNCH BLADES 09/16/1980
K840305 IMM ENTERPRISES LTD. CATEGORY 1 CIRCULATORY SYSTEM DEVICE 04/23/1984
K891000 INSTROMEDIX, INC. MODIFIED EXTERNAL PAD 05/19/1989
K830471 INTL. MEDICAL PROSTHETICS RESEARCH KELLY-WICK TANNELER 03/24/1983
K771625 J. JAMNER SURGICAL INSTRUMENTS, INC. LEININGEO AORTIC PUNCH #310-395 & 397 09/12/1977
K861745 KEELER INSTRUMENTS, INC. VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET 05/13/1986
K851834 MANAN MANUFACTURING CO., INC. MANAN GWI GUIDE WIRE INTRODUCER 07/11/1985
K851833 MANAN MANUFACTURING CO., INC. MANAN SELDINGER NEEDLE 07/11/1985
K851832 MANAN MANUFACTURING CO., INC. NAMAN POTTS COURNAND NEEDLE 07/11/1985
K760087 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. TAPE, VASCULAR, 1/4" DACRON 07/20/1976
K822829 MEDCO PRODUCTS, CO., INC. ROTARY VASCULAR KNIFE 11/17/1982
K761328 MEDICAL ENGINEERING CORP. ANASTOMASIS OCCLUDER 02/01/1977
K781336 MEDICAL ENGINEERING CORP. SURGITEK DISPOSABLE FLO-RESTER 10/10/1978
K810890 MEDICAL MARKETING SYSTEMS NEOLOOPS 08/31/1981
K881392 MEDICAL/SURGICAL SPECIALTIES, LTD. CARDICAD(TM) 05/31/1988
K864461 MEDSURG INDUSTRIES, INC. MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY 11/24/1986
K882479 MEDTRONIC BLOOD SYSTEMS, INC. 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP 07/18/1988
K022238 MEDTRONIC VASCULAR MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 10/09/2002
K882367 METATECH CORP. METATECH MICROCLIP APPLICATOR 08/25/1988
K790124 NARCO SCIENTIFIC GRAFT TUNNELER 02/08/1979
K760645 PILLING CO. CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP 09/21/1976
K760646 PILLING CO. CAROTID ARTERY CLAMP W/PILLING LMM 09/21/1976
K760648 PILLING CO. TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS 09/21/1976
K962771 PILLING WECK, INC. BURKE CONGENITAL THORACOSCOPY INSTRUMENTS 11/19/1996
K893436 PIONEERING TECHNOLOGIES, INC. MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT 07/14/1989
K883135 PIONEERING TECHNOLOGIES, INC. PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) 09/26/1988
K882981 PIONEERING TECHNOLOGIES, INC. PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP 09/27/1988
K841468 PROFESSIONAL MEDICAL SERVICES PMA ANGIOGRAPHY TRAY 06/05/1984
K823764 SCANLAN INTL., INC. SCANLAN SINGLE-USE AORTA PUNCH 03/24/1983
K851825 SCANLAN INTL., INC. SCANLAN TUNNELER, SHEATH & TIP 07/12/1985
K760351 SHERWOOD MEDICAL INDUSTRIES CATHETER, ARGYLE THORACIC 08/23/1976
K760136 SHERWOOD MEDICAL INDUSTRIES CATHETER, THORACIC DRAIN 07/20/1976
K874960 SOLWAY, INC. CARDIOVASCULAR SURGICAL INSTRUMENTS 02/05/1988
K900379 ST. JUDE MEDICAL, INC. HYCULT DIAMOND CORONARY BYPASS KNIFE 03/19/1990
K851140 TELEFLEX MEDICAL, INC. TELEFLEX MEDICAL INTRODUCER NEEDLE 06/19/1985
K801393 TEXAS MEDICAL PRODUCTS, INC. AIR ASPIRATOR NEEDLE 06/30/1980
K780247 THORATEC LABORATORIES CORP. IMPCO DISPOSABLE AORTIC PUNCH 02/27/1978
K881796 UNIVERSAL MEDICAL INSTRUMENT CORP. UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE 07/26/1988
K760791 V. MUELLER O.V. BAXTER HEALTHCARE CORP. COOLEY ANGLED SCISSOR - 1MM PROBE POINT 11/11/1976
K760792 V. MUELLER O.V. BAXTER HEALTHCARE CORP. SCISSOR - 1.5MM PROBE POINT, ANGLED 11/11/1976
K850394 VASCUTECH, INC. LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR 04/24/1985
K844584 W.L. GORE & ASSOCIATES,INC GORE-TEX TUNNELER 01/24/1985


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