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Cardiovascular

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

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RecordFirmDate
S670 OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S014)Medtronic, Ireland1999-11-16
LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING (P960016/S002)St Jude Medical1999-11-15
VITATRON DIVA IMPLANTABLE PULSE GENERATORS (P990001/S002)Medtronic, Inc.1999-11-12
TENDRIL/PASSIVE PLUS/AV PLUS DX (P960030/S006)ABBOTT MEDICAL1999-11-10
VITATRON DIVA (P990001/S001)Medtronic, Inc.1999-11-10
TENDRIL/PASSIVE PLUS/AV PLUS DX (P960013/S006)ABBOTT MEDICAL1999-11-10
TENDRIL/PASSIVE PLUS/AV PLUS DX (P880086/S065)ABBOTT MEDICAL1999-11-10
HEART LASER CO2 TMR SYSTEM (P950015/S003)Laser Engineering Heart, Inc.1999-11-10
DELTA/VISTA PACEMAKERS (P910077/S029)Boston Scientific1999-11-05
DELTA/VISTA PACEMAKERS (P840068/S038)Boston Scientific1999-11-05
NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM (P980001/S013)Boston Scientific Corp1999-11-04
PTCA CATHETERS (P860019/S157)Scimed Life Systems, Inc.1999-11-03
ACS OTW PHOTON CORONARY DILATATION CATHETER (P810046/S199)Advanced Cardiovascular Systems, Inc.1999-10-29
RX5000 PROGRAMMER (P830026/S076)Boston Scientific1999-10-29
OMNISCIENCE CARDIAC VALVE (P830039/S010)Medical Cv, Inc.1999-10-29
VASOSEAL (VASCULAR HEMOSTASIS DEVICE) (P920004/S011)St. Jude Medical, Inc.1999-10-22
CARPENTIER EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S010)Edwards Lifesciences, LLC1999-10-22
CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S012)Edwards Lifesciences, LLC1999-10-22
CARPENTIER EDWARDS BIOPROSTHESIS (P870056/S012)Edwards Lifesciences, LLC1999-10-22
DISCOVERY/MERIDIAN (P940031/S020)Boston Scientific1999-10-22
THIN LINE AND FINELINE PACING LEADS (P960004/S007)Boston Scientific1999-10-21
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S045)ABBOTT MEDICAL1999-10-21
DISCOVERY/MERIDIAN PACEMAKER SYSTEMS (P940031/S021)Boston Scientific1999-10-20
ANCURE TUBE AND BIFURCATED SYSTEMS & ILIAC BALLOON CATHETER (P990017/S001)Boston Scientific Corp1999-10-20
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S029)Boston Scientific Corp1999-10-15
CADENCE TIERED-THERAPYDEFIBRILLATOR SYSTEM (P910023/S044)ABBOTT MEDICAL1999-10-13
SIMPSON CORONARY ATHEROCATH-GTO (P890043/S034)Abbott Vascular1999-10-12
SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS (P890043/S033)Abbott Vascular1999-09-30
HANCOCK 1 STANDARD BIOPROSTHETIC VALVE (P870078/S005)Medtronic, Inc.1999-09-29
HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES (P790007/S016)Medtronic Heart Valves1999-09-29
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S009)Medtronic, Inc.1999-09-29
MEDTRONIC HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S035)Medtronic Cardiac Surgery1999-09-29
ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS (P910073/S027)Boston Scientific1999-09-29
ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM (P990017)Boston Scientific Corp1999-09-28
ANEURX STENT GRAFT SYSTEM (P990020)Medtronic Vascular1999-09-28
HANCOCK II PORCINE BIOPROSTHESIS (P980043)Medtronic, Inc.1999-09-28
THINLINE/FINELINE (P960004/S008)Boston Scientific1999-09-27
DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2 (P990001)Medtronic, Inc.1999-09-27
COOK MBC PTCA BALLOON DILATATION CATHETER (P990008)Cook, Inc.1999-09-27
CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S045)ABBOTT MEDICAL1999-09-27
R5.111WE(REVISION OF R5.85WE) (P900070/S025)St. Jude Medical, Cardiac Rhythm Management Divisi1999-09-24
NETWORK PROGRAMMER (P880038/S035)St. Jude Medical, Inc.1999-09-24
RX5000 PROGRAMMER (P830026/S075)Boston Scientific1999-09-24
CARDIAC PACEMAKER PROGRAMMER & BASE STATION (P880086/S068)ABBOTT MEDICAL1999-09-24
NETWORK PROGRAMMER (P820018/S073)St. Jude Medical, Inc.1999-09-24
CARDIAC PACEMAKER PROGRAMMER & BASE STATION (P830045/S067)St. Jude Medical, Inc.1999-09-24
SOFTWARE MODEL 3264 REV A (P880006/S030)St. Jude Medical, Inc.1999-09-24
MEDTRONIC SPRINT FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS (P920015/S016)Medtronic, Inc.1999-09-24
SCIMED RADIUS CORONARY STENT (P970061/S007)Boston Scientific Scimed, Inc.1999-09-17
ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S001)Cryolife, Inc.1999-09-17
TECHSTAR XL 6 FR. PERCUTANEOUS VASCULAR SURGICAL DEVICES (P960043/S020)Abbott Vascular, Inc.1999-09-16
BRIO CARDIAC PACEMAKERS (P950029/S007)MicroPort CRM USA, Inc.1999-09-16
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S026)Boston Scientific Corp1999-09-16
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024/S002)Medtronic, Inc.1999-09-16
DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049)MicroPort CRM USA, Inc.1999-09-15
ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT (P970024/S003)MicroPort CRM USA, Inc.1999-09-14
GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER (P850049/S007)Cook, Inc.1999-09-14
CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES (P900043/S015)Cordis Corp.1999-09-14
PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM (P980023/S002)Biotronik, Inc.1999-09-13
POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S (P880086/S047)ABBOTT MEDICAL1999-09-13
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S021)Terumo Medical Corporation1999-09-10
EXTERNAL PULSE GENERATOR (P820003/S074)Medtronic Cardiac Rhythm Disease Management1999-09-01
PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS (P960030/S005)ABBOTT MEDICAL1999-08-26
BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE (P950029/S005)MicroPort CRM USA, Inc.1999-08-25
ACTROS+ FAMILY OF PULSE GENERATORS (P950037/S008)Biotronik, Inc.1999-08-24
GEMNOS & DROMOS SL PULSE GENERATORS (P820076/S022)Biotronik, Inc.1999-08-24
ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM (P970020/S018)Abbott Vascular, Inc.1999-08-13
MODEL 7271 GEM DR ICD (P980016/S007)Medtronic Cardiac Rhythm Disease Management1999-08-12
CAPSURE SP NOVUS MODEL 5092 (AND VITATRON EXCELLENCE SS+ MODEL IML 49B) (P850089/S042)Medtronic Cardiac Rhythm Disease Management1999-08-11
VASOSEAL VHD (P920004/S010)St. Jude Medical, Inc.1999-08-10
HEARTMATE IP & VE LVAS (P920014/S009)Thoratec Corp1999-08-10
MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE (P980035/S002)Medtronic, Inc.1999-08-09
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S028)Boston Scientific Corp1999-08-09
VENTRITEX HOUSECALL RECEIVER/TRANSMITTER (P910023/S043)ABBOTT MEDICAL1999-08-04
ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U (P950037/S007)Biotronik, Inc.1999-08-04
NIR ON RANGER PREMOUNTED STENT SYSTEMS (P980001/S002)Boston Scientific Corp1999-08-03
SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR (P960042/S004)Spectranetics (Philips)1999-08-03
MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT (P980009/S002)Boston Scientific Scimed, Inc.1999-07-28
MASTERS SERIES COATED AORTIC VALVED GRAFT(MODEL CAVGJ-514) (P810002/S049)ABBOTT MEDICAL1999-07-28
AFFINITY/ENTITY DR,DC,SR (P880086/S066)ABBOTT MEDICAL1999-07-27
MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980016/S003)Medtronic Cardiac Rhythm Disease Management1999-07-27
ADDVENT/AV PLUS DX (P880086/S064)ABBOTT MEDICAL1999-07-23
NIR PREMOUNTED STENT SYSTEMS (P980001/S010)Boston Scientific Corp1999-07-22
D114S OVER-THE-WIRE BALLOON DILATATION CATHETER (P790017/S069)Medtronic, Ireland1999-07-22
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03 (P830045/S065)St. Jude Medical, Inc.1999-07-21
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03 (P880086/S063)ABBOTT MEDICAL1999-07-21
WALLSTENT TIPS ENDOPROSTHESIS (P930031/S006)Boston Scientific Corp1999-07-21
NIR PREMOUNTED STENT SYSTEMS (P980001/S009)Boston Scientific Corp1999-07-01
FINELINE (P960004/S005)Boston Scientific1999-07-01
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM/31MM RADIUS OTW & 31 MM RADIUS SOE (P970061/S006)Boston Scientific Scimed, Inc.1999-06-30
MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS (P940031/S019)Boston Scientific1999-06-29
AFFINITY SR/DR (P880086/S062)ABBOTT MEDICAL1999-06-21
LIVEWIRE TC CARDIAC ABLATION SYSTEM-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY (P960016/S001)St Jude Medical1999-06-18
AFFINITY DR & DC; ENTITY DR & DC (P880086/S061)ABBOTT MEDICAL1999-06-17
MEDTRONIC CAPSURE SP NOVUS MODEL 4092 VITATRON EXCELLENCE PS+ MODEL IMK 49B TRANVENOUS VENTRICULAR LEAD (P830061/S030)Medtronic Cardiac Rhythm Disease Management1999-06-16
MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P900061/S038)Medtronic Cardiac Rhythm Disease Management1999-06-16
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S027)Boston Scientific Corp1999-06-16
MEDTRONIC MODEL 7273 GEM II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980016/S006)Medtronic Cardiac Rhythm Disease Management1999-06-16
ENDOTAK ENDURANCE EZ ENDOCARDIAL DIFIBRILLATION LEAD (P910073/S026)Boston Scientific1999-06-15
CHILLI COOLED ABLATION SYSTEM (P980003/S001)Boston Scientific Corp1999-06-14
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