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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
NIROYAL(TM) ADVANCE PREMOUNTED STENT SYSTEM (P980001/S014)Boston Scientific Corp2000-07-13
PALMAZ BALLOON EXPANDABLE STENT (P890017/S009)Cordis US Corporation2000-07-11
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S047)Boston Scientific Corp2000-07-11
PALMZ BALLOON EXPANDABLE STENTS (P890017/S008)Cordis US Corporation2000-07-11
EXTREME XTO .9 MM CORONARY ANGIOPLASTY CATHETER (P910001/S015)Spectranetics Corp.2000-07-11
NINJA FX PTCA DILATATION CATHETER (P880003/S080)Cordis Corp.2000-07-07
VENTRITEX(R) TVL(R) LEAD SYSTEM (P950022/S009)ABBOTT MEDICAL2000-07-06
S660 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S021)Medtronic, Ireland2000-06-30
MASTERS SERIES VALVE: PTFE SEWING CUFF (P810002/S052)ABBOTT MEDICAL2000-06-30
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S020)Corcym S.r.l.2000-06-29
SCIMED PTCA CATHETERS (P860019/S164)Scimed Life Systems, Inc.2000-06-29
ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD (P950001/S007)Boston Scientific2000-06-29
PHILOS PULSE GENERATOR (P950037/S011)Biotronik, Inc.2000-06-28
MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS (P880006/S032)St. Jude Medical, Inc.2000-06-26
MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS (P830045/S070)St. Jude Medical, Inc.2000-06-26
MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS (P880086/S073)ABBOTT MEDICAL2000-06-26
HEARTMATE IP & VE LVAS (P920014/S012)Thoratec Corp2000-06-23
ACS MULTI-LINK RX DUET (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS (P970020/S024)Abbott Vascular, Inc.2000-06-23
ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM (P900023/S033)Abiomed Cardiovascular, Inc.2000-06-22
PHILOS PULSE GENERATOR FAMILY AND SWM1000 B-K-00.0U SOFTWARE CARTRIDGE (P950037/S012)Biotronik, Inc.2000-06-22
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037)Vascular Solutions, Inc.2000-06-22
DISCOVERY/MERIDIAN/PULSAR PACEMAKERS (P940031/S024)Boston Scientific2000-06-20
ACTROS FAMILY OF PULSE GENERATORS (P950037/S014)Biotronik, Inc.2000-06-20
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE, MODELS 2700 AND 2800 (P860057/S013)Edwards Lifesciences, LLC2000-06-16
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS, MODELS 6625LP/ESR (P870077/S011)Edwards Lifesciences, LLC2000-06-16
CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S013)Edwards Lifesciences, LLC2000-06-16
MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER (P880086/S072)ABBOTT MEDICAL2000-06-15
MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER (P880006/S031)St. Jude Medical, Inc.2000-06-15
NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER (P990025)Biosense Webster, Inc.2000-06-15
MODEL 3264 REV. B PROGRAMMER SOFTWARE FOR THE APSU MODEL 3250 PROGRAMMER (P830045/S069)St. Jude Medical, Inc.2000-06-15
MEDTRONIC MODEL 7271 GEM DR ICD (P980016/S011)Medtronic Cardiac Rhythm Disease Management2000-06-15
QUANTUM RANGER, NC RANGER, COYOTE, AND MAXXUM PTCA CATHETERS (P860019/S163)Scimed Life Systems, Inc.2000-06-14
MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF (P980050)Medtronic, Inc.2000-06-14
NIR (TM) W/SOX PREMOUNTED STENT DELIVERY SYSTEM (P980001/S020)Boston Scientific Corp2000-06-13
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S046)Boston Scientific Corp2000-06-13
THINLINE(TM)II/FINELINE(TM) II LEADS (P960004/S013)Boston Scientific2000-06-09
THINLINE II/ FINELINE II PACING LEADS (P960004/S012)Boston Scientific2000-06-07
ROTAGLIDE(TM) LUBRICANT (P900056/S045)Boston Scientific Corp2000-06-06
CROSSSAIL/OPENSAIL CORONARY DILATATION CATHETER (P810046/S201)Advanced Cardiovascular Systems, Inc.2000-06-05
STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071)Biosense Webster, Inc.2000-05-31
MODEL 6577 STERILIZABLE TELEMETRY WAND (P830060/S048)Boston Scientific2000-05-30
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S033)Boston Scientific Corp2000-05-30
BIOSENSE WEBSTER TEMPERATURE CABLES (P950005/S008)Biosense Webster, Inc.2000-05-30
NIR W/SOX PREMOUNTED STENT DELIVERY SYSTEM (P980001/S019)Boston Scientific Corp2000-05-30
NIROYAL ADVANCE PREMOUNTED STENT SYSTEM (P980001/S006)Boston Scientific Corp2000-05-24
PALMAZ-SCHATZ(R) MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY(TM) OVER THE WIRE DELIVERY SYSTEM (P900043/S023)Cordis Corp.2000-05-24
CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES (P960043/S023)Abbott Vascular, Inc.2000-05-19
CLOSER 6 FR. SUTURE MEDIATED CLOSURE DEVICE (P960043/S024)Abbott Vascular, Inc.2000-05-19
IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS (P950001/S006)Boston Scientific2000-05-19
CLOSER 6 FR. SUTURE-MEDIATED CLOSURE DEVICE (P960043/S022)Abbott Vascular, Inc.2000-05-19
MODEL 2920 (PRM) SYSTEM ZOOM (DELTA PACEMAKER SYSTEM) (P840068/S039)Boston Scientific2000-05-18
TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER (P950029/S006)MicroPort CRM USA, Inc.2000-05-18
MODEL 2920 PRM SYSTEM ZOOM (VENTAK PRX AICD SYSTEM) (P910077/S031)Boston Scientific2000-05-18
MODEL 2920 (PRM) SYSTEM ZOOM (VIGOR DR/SR PACEMAKER SYSTEM) (P940031/S023)Boston Scientific2000-05-18
MODEL 2920 (PRM) SYSTEM ZOOM (VENTAK AV AICD SYSTEM) (P960040/S013)Boston Scientific2000-05-18
DEFENDER IV MODEL 612 DUAL-CHAMBER, RATE-RESPONSIVE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, ELA MEDICAL PROMGRAMMER (P980049/S001)MicroPort CRM USA, Inc.2000-05-18
ACS MULTI-LINK RX TRISTAR/ACS MULTI-LINK OTW TRISTAR (P970020/S022)Abbott Vascular, Inc.2000-05-16
S670 W/DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S020)Medtronic, Ireland2000-05-16
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S044)Boston Scientific Corp2000-05-15
ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S032)Abiomed Cardiovascular, Inc.2000-05-12
BX VELOCITY(TM) STENT WITH RAPTOR OVER-THE WIRE DELIVERY SYSTEM (P900043/S020)Cordis Corp.2000-05-11
S670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM (P970035/S019)Medtronic, Ireland2000-05-11
KAPPA 706 SR IPG (P980035/S007)Medtronic, Inc.2000-05-11
SELUTE(R) PICOTIP(TM) STEROID-ELUTING ENDOCARDIAL ATRIAL-J LEADS (P950001/S004)Boston Scientific2000-05-10
S660TM WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S017)Medtronic, Ireland2000-05-09
MASTERS SERIES COATED AORTIC VALVED GRAFT (P810002/S051)ABBOTT MEDICAL2000-05-05
WALLSTENT ILIAC ENDOPROSTHESIS (P940019/S005)Boston Scientific Scimed, Inc.2000-05-05
WALLSTENT(R) TIPS ENDOPROSTHESIS AND UNISTEP(TM) PLUS DELIVERY SYSTEM (P930031/S007)Boston Scientific Corp2000-05-04
PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S003)Biotronik, Inc.2000-05-01
RAPTOR PTCA DILATATION CATHETER (P880003/S079)Cordis Corp.2000-04-27
BOSTON SCIENTIFIC SCIMED PTCA CATHETERS (P880027/S057)Boston Scientific2000-04-26
SCIMED PTCA CATHETER (P860019/S161)Scimed Life Systems, Inc.2000-04-26
NIR PREMOUNTED STENT SYSTEM (P980001/S018)Boston Scientific Corp2000-04-25
ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S028)Boston Scientific2000-04-20
VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD (P950022/S008)ABBOTT MEDICAL2000-04-19
FLEXATOME CUTTING BALLOON (P950020)Boston Scientific Corp2000-04-18
ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER (P990017/S006)Boston Scientific Corp2000-04-14
ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM (P900023/S031)Abiomed Cardiovascular, Inc.2000-04-14
ANEURX STENT GRAFT SYSTEM (P990020/S004)Medtronic Vascular2000-04-12
ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES (P910073/S031)Boston Scientific2000-04-11
ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD, SQ PATCH LEAD, EPICARDIAL PATCHES (P910077/S032)Boston Scientific2000-04-11
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S043)Boston Scientific Corp2000-04-11
VASOSEAL ES (ES DEVICE) (P920004/S012)St. Jude Medical, Inc.2000-04-10
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S041)Boston Scientific Corp2000-04-10
CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM (P900043/S019)Cordis Corp.2000-04-06
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S022)Terumo Medical Corporation2000-04-06
INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS (P880086/S070)ABBOTT MEDICAL2000-04-06
AFFINITY VDR MODEL 5430 PULSE GENERATOR (P880086/S071)ABBOTT MEDICAL2000-04-06
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S042)Boston Scientific Corp2000-04-04
N (P980037/S001)Boston Scientific Corp2000-04-03
ROTAGLIDE LUBRICANT STERILIZATION VESSEL CHANGE (P900056/S039)Boston Scientific Corp2000-04-01
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM FLOPPY GOLD GUIDE WIRE (P900056/S040)Boston Scientific Corp2000-04-01
THINLINE ENDOCARDIAL PACING LEADS (P960004/S010)Boston Scientific2000-03-29
EVT ABDOMINAL AORTIC TUBE/EVT ABDOMINAL AORTIC BIF (P990017/S003)Boston Scientific Corp2000-03-29
PTCA CATHETER (P860019/S159)Scimed Life Systems, Inc.2000-03-24
ANCURE ENDOGRAFT SYSTEM/ANCURE ILIAC BALLOON CATHETER (P990017/S005)Boston Scientific Corp2000-03-24
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S038)Boston Scientific Corp2000-03-24
ANGIO-SEAL (P930038/S024)Terumo Medical Corporation2000-03-23
MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT (P980009/S005)Boston Scientific Scimed, Inc.2000-03-23
ECLIPSE TMR HOLMIUN LASER SYSTEM (P970029/S003)Cryolife, Inc.2000-03-22
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