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Cardiovascular

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

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RecordFirmDate
MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S004)Medtronic, Inc.1998-09-22
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S005)Medtronic, Inc.1998-09-18
NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE (P790017/S067)Medtronic, Ireland1998-09-18
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S004)Medtronic, Inc.1998-09-18
SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S143)Scimed Life Systems, Inc.1998-09-16
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S003)Boston Scientific Scimed, Inc.1998-09-15
APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P880006/S027)St. Jude Medical, Inc.1998-09-04
APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P880086/S045)ABBOTT MEDICAL1998-09-04
14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE (P960042/S002)Spectranetics (Philips)1998-09-04
APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P830045/S056)St. Jude Medical, Inc.1998-09-04
VENTRITEK CONTOUR II TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P910023/S035)ABBOTT MEDICAL1998-09-03
APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P880086/S046)ABBOTT MEDICAL1998-09-03
TEMPO PULSE GENERATORS (P900070/S022)St. Jude Medical, Cardiac Rhythm Management Divisi1998-09-03
ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S024)Boston Scientific Corp1998-09-02
LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES (P930012/S011)Progressive Angioplasty Systems, Inc.1998-09-02
PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM (P960043/S005)Abbott Vascular, Inc.1998-09-02
CAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS (P930039/S005)Medtronic, Inc.1998-09-01
VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION (P960040/S006)Boston Scientific1998-08-31
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER (P860008/S016)Cardio Command1998-08-28
BONNIE (TM) PTCA CATHERS (P880027/S052)Boston Scientific1998-08-27
MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB (P830061/S027)Medtronic Cardiac Rhythm Disease Management1998-08-27
DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S037)Boston Scientific1998-08-26
CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS (P860057/S006)Edwards Lifesciences, LLC1998-08-26
VIGOR PACEMAKERS, MODELS 460 AND 1130 (P940031/S014)Boston Scientific1998-08-26
LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE (P930012/S012)Progressive Angioplasty Systems, Inc.1998-08-25
SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S140)Scimed Life Systems, Inc.1998-08-24
MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S017)Boston Scientific1998-08-21
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S010)Cordis Corp.1998-08-20
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S006)Medtronic, Inc.1998-08-20
HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE (P790007/S014)Medtronic Heart Valves1998-08-20
THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION (P950015)Laser Engineering Heart, Inc.1998-08-20
SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S129)Scimed Life Systems, Inc.1998-08-20
HANCOCK PORCINE BIOPROSTHETIC HEART VALVE (P870078/S004)Medtronic, Inc.1998-08-20
ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM DEFIBRILLATION LEAD SYSTEM. (P970024)MicroPort CRM USA, Inc.1998-08-19
ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S012)Medtronic, Inc.1998-08-14
ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM (P950037/S003)Biotronik, Inc.1998-08-13
ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD (P910073/S024)Boston Scientific1998-08-13
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S002)Biotronik, Inc.1998-08-13
SUREFIX TM MODEL 5072 LEAD (P930039/S006)Medtronic, Inc.1998-08-12
CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS (P850089/S039)Medtronic Cardiac Rhythm Disease Management1998-08-12
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024/S001)Medtronic, Inc.1998-08-12
MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB (P830061/S028)Medtronic Cardiac Rhythm Disease Management1998-08-12
MODEL 6943 AND 6945 (P920015/S014)Medtronic, Inc.1998-08-12
MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE (P890003/S055)Medtronic, Inc.1998-08-12
NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM (P980001)Boston Scientific Corp1998-08-11
SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S146)Scimed Life Systems, Inc.1998-08-10
CHARGER PTCA DILATATION CATHETERS (P880003/S074)Cordis Corp.1998-08-10
CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (P870056/S006)Edwards Lifesciences, LLC1998-08-07
COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P910020/S023)Boston Scientific1998-08-06
SCIMED COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S147)Scimed Life Systems, Inc.1998-08-06
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S033)Medtronic Cardiac Surgery1998-08-06
COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P830026/S073)Boston Scientific1998-08-06
ROTAWIRE FLOPPY GOLD GUIDE WIRE/ROTABLATOR SYSTEMS GUIDE WIRE LINE (P900056/S022)Boston Scientific Corp1998-08-06
ACS MULTI-LINK TM CORONARY STENT SYSTEM WITH THE 25MM STENT LENGTH (P970020/S001)Abbott Vascular, Inc.1998-08-04
CORDIS TITAN & TITAL XL DILATION CATHETERS (P880003/S071)Cordis Corp.1998-08-04
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S012)Cordis Corp.1998-08-04
DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S036)Boston Scientific1998-07-31
VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS (P910077/S023)Boston Scientific1998-07-31
ACS RX ESPRIT CORONARY DILATION CATHETER (P810046/S190)Advanced Cardiovascular Systems, Inc.1998-07-30
SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S136)Scimed Life Systems, Inc.1998-07-29
MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S015)Boston Scientific1998-07-24
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S043)ABBOTT MEDICAL1998-07-23
DIAGNOSTIC/ABLATION DEFLECTABLE BRAIDED-TIP CATHETER (WITHOUT THERMOCOUPLE) & CELSIUS (WITH THERMOCOUPLE) (P950005/S002)Biosense Webster, Inc.1998-07-22
THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S007)Thoratec Laboratories Corp.1998-07-20
TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S008)Abbott Vascular, Inc.1998-07-17
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S016)Terumo Medical Corporation1998-07-17
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061)Boston Scientific Scimed, Inc.1998-07-16
APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P830045/S058)St. Jude Medical, Inc.1998-07-14
POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S (P880086/S048)ABBOTT MEDICAL1998-07-14
MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE (P890003/S057)Medtronic, Inc.1998-07-14
POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S (P880086/S049)ABBOTT MEDICAL1998-07-14
APSU PROGRAMMER, APSU SOFTWARE, BASE STATION (P830045/S057)St. Jude Medical, Inc.1998-07-14
ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE (P810002/S047)ABBOTT MEDICAL1998-07-14
MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S003)Medtronic, Inc.1998-07-14
SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S145)Scimed Life Systems, Inc.1998-07-10
MICRO STENT TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL (P970035/S003)Medtronic, Ireland1998-07-10
INTERTACH II MODELS 262-16 (P860007/S020)Boston Scientific1998-07-06
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S032)Medtronic Cardiac Surgery1998-07-01
ACS RX ROCKET CORONARY DILATION CATHETER (P810046/S188)Advanced Cardiovascular Systems, Inc.1998-06-29
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S011)Cordis Corp.1998-06-29
SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S131)Scimed Life Systems, Inc.1998-06-29
ACS RX ESPRIT CORONARY DILATION CATHETER (P810046/S189)Advanced Cardiovascular Systems, Inc.1998-06-27
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S009)Cordis Corp.1998-06-24
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S003)Medtronic, Inc.1998-06-16
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S012)Terumo Medical Corporation1998-06-16
SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH (P960042/S001)Spectranetics (Philips)1998-06-16
LOCATOR STEERABLE STYLET MODEL 4036 (P960013/S002)ABBOTT MEDICAL1998-06-15
BONNIE TM SLIDING RAIL PTCA CATHETERS (P880027/S055)Boston Scientific1998-06-15
CHAMPION WRAP PTCA CATHETER (P930012/S010)Progressive Angioplasty Systems, Inc.1998-06-15
VASOSEAL ANCHOR DEVICE (P920004/S009)St. Jude Medical, Inc.1998-06-12
SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS (P900060/S017)Corcym S.r.l.1998-06-11
ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC (P810046/S185)Advanced Cardiovascular Systems, Inc.1998-06-08
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S008)Cordis Corp.1998-06-08
ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM (P890043/S032)Abbott Vascular1998-06-08
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S010)Terumo Medical Corporation1998-06-03
SUREFIX TM MODEL 5072 LEAD (P930039/S004)Medtronic, Inc.1998-06-03
MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD (P890003/S050)Medtronic, Inc.1998-06-03
CHARGER PTCA DILATATION CATHETERS (P880003/S072)Cordis Corp.1998-06-03
CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS (P850089/S038)Medtronic Cardiac Rhythm Disease Management1998-06-01
DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S035)Boston Scientific1998-05-28
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