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Cardiovascular

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

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RecordFirmDate
ACS MULTI-LINK DUET & TRISTAR CORONARY STENT SYSTEM (P970020/S020)Abbott Vascular, Inc.2000-03-20
NIR PREMOUNTED STENT SYSTEMS (P980001/S012)Boston Scientific Corp2000-03-20
SPECTRANETICS LASER SHEATHS (SLS) (P960042/S005)Spectranetics (Philips)2000-03-17
POSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE (P980037/S002)Boston Scientific Corp2000-03-17
ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT (P910001/S017)Spectranetics Corp.2000-03-17
CHILLI COOLED ABLATION SYSTEM (P990054)Boston Scientific Corp2000-03-17
NIR W/SOX PREMOUNTED STENT SYSTEM (P980001/S011)Boston Scientific Corp2000-03-16
ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM (P900023/S030)Abiomed Cardiovascular, Inc.2000-03-13
CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR (P950005/S007)Biosense Webster, Inc.2000-03-13
VENTAK PRX AICD SYSTEM (P910077/S030)Boston Scientific2000-03-10
SELUTE(R) STEROID-ELUTING LEAD (P950001/S005)Boston Scientific2000-03-10
ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM (P910073/S029)Boston Scientific2000-03-10
SWEET TIP RX STEROID ELUTING LEAD (P960006/S003)Boston Scientific2000-03-10
VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P830060/S046)Boston Scientific2000-03-10
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S019)Terumo Medical Corporation2000-03-08
THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER) (P950015/S005)Laser Engineering Heart, Inc.2000-03-08
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S037)Boston Scientific Corp2000-03-08
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S036)Boston Scientific Corp2000-03-08
TENDRIL SDX (P960013/S007)ABBOTT MEDICAL2000-03-07
CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES (P960043/S021)Abbott Vascular, Inc.2000-03-02
GEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR (P900061/S041)Medtronic Cardiac Rhythm Disease Management2000-03-02
CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM (P900043/S022)Cordis Corp.2000-03-02
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S023)Terumo Medical Corporation2000-03-01
ST. JUDE MEDICAL MECHANICAL HEART VAVLE (P810002/S050)ABBOTT MEDICAL2000-02-28
NIR(TM) PREMOUNTED STENT SYSTEMS (P980001/S016)Boston Scientific Corp2000-02-25
CROSSFLEX LC BALLOON EXPANDABLE STENT WITH OTW DELIVERY SYSTEM (P900043/S018)Cordis Corp.2000-02-25
MODEL 6698 PATIENT TEST MAGNET (P940031/S022)Boston Scientific2000-02-25
THINLINE/FINELINE ENDOCARDIAL PACING LEADS (P960004/S011)Boston Scientific2000-02-23
ANGIOPLASTY (PTCA) CATHETER (P860019/S158)Scimed Life Systems, Inc.2000-02-23
FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S008)Medtronic, Inc.2000-02-23
ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM (P910073/S030)Boston Scientific2000-02-23
VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P830060/S047)Boston Scientific2000-02-23
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO (P830045/S068)St. Jude Medical, Inc.2000-02-18
TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO (P880086/S069)ABBOTT MEDICAL2000-02-18
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO (P900070/S026)St. Jude Medical, Cardiac Rhythm Management Divisi2000-02-18
ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER (P810046/S200)Advanced Cardiovascular Systems, Inc.2000-02-16
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S034)Boston Scientific Corp2000-02-16
ARTEGRAFT BOVINE HETEROGRAFT (N16837/S003)LeMaitre Vascular, Inc.2000-02-11
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S035)Boston Scientific Corp2000-02-11
RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S008)Boston Scientific Scimed, Inc.2000-02-11
ANEURX STENT GRAFT SYSTEM (P990020/S002)Medtronic Vascular2000-02-08
ANEURX STENT GRAFT SYSTEM (P990020/S003)Medtronic Vascular2000-02-08
PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM (P900043/S021)Cordis Corp.2000-02-04
MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER (P920032/S005)Pace Medical2000-02-02
CELLSIUS INTERFACE CABLES (AUTOCLAVABLE) (P950005/S006)Biosense Webster, Inc.2000-02-01
MAXXUM PTCA CATHETER (P860019/S156)Scimed Life Systems, Inc.2000-02-01
PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH HEPACOAT OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES (P900043/S017)Cordis Corp.2000-02-01
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S032)Boston Scientific Corp2000-01-28
PALMAZ BALLOON EXPANDABLE STENTS (P890017/S007)Cordis US Corporation2000-01-28
CAPSUREZ NOVUS (P850089/S044)Medtronic Cardiac Rhythm Disease Management2000-01-28
CAPSURE Z/SP (P850089/S043)Medtronic Cardiac Rhythm Disease Management2000-01-28
3500/3510 PROGRAMMER (P830045/S066)St. Jude Medical, Inc.2000-01-28
REGENCY SC+, REGENCY SC, REGENCY SCX (P880006/S029)St. Jude Medical, Inc.2000-01-28
SUREFIX (P930039/S007)Medtronic, Inc.2000-01-28
3500/3510 PROGRAMMER (P880086/S067)ABBOTT MEDICAL2000-01-28
VITESSE-C OS CATHETER MODELS 114-009, 117-016, AND 120-009 (P910001/S014)Spectranetics Corp.2000-01-28
CAPSURE/CAPSURESP/NOVUS (P830061/S031)Medtronic Cardiac Rhythm Disease Management2000-01-28
CAPSUREFIX/SUREFIX (P930039/S008)Medtronic, Inc.2000-01-28
VENTAK PRIZM DR/VR AICD (P960040/S012)Boston Scientific2000-01-21
VENTRITEX SPL LEAD SYSTEM (P950022/S007)ABBOTT MEDICAL2000-01-20
STYLET ACCESSORY KIT (P830060/S045)Boston Scientific2000-01-19
ANCURE TUBE AND BIFURCATED ENDOVASCULAR SYSTEMS (P990017/S002)Boston Scientific Corp2000-01-13
HEART LASER(TM) CO2 TMR SYSTEM (P950015/S006)Laser Engineering Heart, Inc.2000-01-11
THINELINE/FINELINE II ENDOCARDIAL PACING LEADS (P960004/S006)Boston Scientific2000-01-07
ANCURE(TM) ENDOGRAFT(R) SYSTEM (P990017/S004)Boston Scientific Corp2000-01-07
TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P880027/S056)Boston Scientific2000-01-07
ST JUDE TORONTO SPV VALVE (P970030/S003)St. Jude Medical, Inc.2000-01-06
REVEAL PLUS INSERTABLE LOOP RECORDER MODEL 9809 SOFTWARE (P890003/S058)Medtronic, Inc.1999-12-27
MODEL 7271 GEM DR ICD (P980016/S010)Medtronic Cardiac Rhythm Disease Management1999-12-23
MEDTRONIC VISION SOFTWARE (P970012/S009)Medtronic, Inc.1999-12-23
MEDTRONIC KAPPA 400/DX2 AND KAPPA 700/600 PACEMAKERS (P980035/S005)Medtronic, Inc.1999-12-23
S540 OVER THE WIRE CORONARY STENT SYSTEM (P970035/S018)Medtronic, Ireland1999-12-22
ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM (P970020/S017)Abbott Vascular, Inc.1999-12-22
ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM (P970020/S019)Abbott Vascular, Inc.1999-12-22
NOVACOR LVAS (P980012/S001)Worldheart, Inc.1999-12-21
MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERS (P980035/S006)Medtronic, Inc.1999-12-20
TCI HEARTMATE(R) 1000A IP LVAD (P920014/S001)Thoratec Corp1999-12-16
LIVEWIRE TC CARDIAC ABLATION CATHETER (P960016/S003)St Jude Medical1999-12-13
GEM II IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR MODELS 7273 & 7229 (P980016/S012)Medtronic Cardiac Rhythm Disease Management1999-12-13
ANEURX STENT GRAFT SYSTEM (P990020/S001)Medtronic Vascular1999-12-10
HEARTMATE IP AND VE LVAS (P920014/S010)Thoratec Corp1999-12-10
CVX-300 EXCIMER LASER SYSTEM (P910001/S016)Spectranetics Corp.1999-12-10
MEDTRONIC 350 SERIES PACING SYSTEM (P980035/S004)Medtronic, Inc.1999-12-09
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S020)Terumo Medical Corporation1999-12-08
MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS (P950029/S008)MicroPort CRM USA, Inc.1999-12-03
IMPLANTABLE PACEMAKER LEADS (P910020/S024)Boston Scientific1999-12-02
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S031)Boston Scientific Corp1999-12-02
IMPLANTABLE PACEMAKER LEADS (P860007/S021)Boston Scientific1999-12-02
IMPLANTABLE PACEMAKER LEAD (P960004/S009)Boston Scientific1999-12-02
IMPLANTABLE PACEMAKER (P830026/S077)Boston Scientific1999-12-02
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S030)Boston Scientific Corp1999-12-02
IMPLANTABLE PACEMAKER LEAD (P940008/S014)Boston Scientific1999-12-02
MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P900061/S036)Medtronic Cardiac Rhythm Disease Management1999-12-02
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S013)Boston Scientific Corp1999-11-30
MAGIC WALLSTENT(R) SELF-EXPANDING CORONARY STENT (P980009/S004)Boston Scientific Scimed, Inc.1999-11-29
ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S028)Abiomed Cardiovascular, Inc.1999-11-24
S670 RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S015)Medtronic, Ireland1999-11-23
VENTRITEX TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA LEAD (P950022/S006)ABBOTT MEDICAL1999-11-23
CLOSER PERCUTANEOUS VASCULAR SURGERY DEVICE (P960043/S019)Abbott Vascular, Inc.1999-11-22
PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG) (P950029/S009)MicroPort CRM USA, Inc.1999-11-19
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