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Cardiovascular

19,134 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
IBC FLOPUMP, MODEL 6000 (K983272)International Biophysics Corp.1999-03-24
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 (K982136)Schiff & Co.1999-03-24
SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 (K984062)Diag Corp.1999-03-24
DIRECTFLOW ARTERIAL CANNULA (K990772)Heartport, Inc.1999-03-23
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF (K983346)Guidant Corp.1999-03-23
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS (K990707)Medtronics Interventional Vascular1999-03-22
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION (K990563)Siemens Medical Solutions USA, Inc.1999-03-19
VASO PRESS SYSTEM (K974393)Britt Corp., Inc.1999-03-19
INTEGRITI PATIENT MONITOR (K980688)Alliance Instruments1999-03-16
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX (K984582)Bio-Detek, Inc.1999-03-16
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER (K990805)Cordis Corp.1999-03-15
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET (K984418)Medrad, Inc.1999-03-11
ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA (K990573)Estech, Inc.1999-03-11
ZOLL M SERIES SPO2 OPTION (K982992)Zoll Medical Corp1999-03-11
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT (K983927)Arterial Vascular Engineering, Inc.1999-03-11
CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM (K983171)Boston Scientific Corp1999-03-11
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 (K984271)Medtronic Vascular1999-03-09
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR (K990514)C.R. Bard, Inc.1999-03-09
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING (K984394)Guidant Corp.1999-03-08
AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 (K981702)Nihon Seimitsu Sokki Co., Ltd.1999-03-05
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280 (K981431)Panasonic Corporation (Panasonic)1999-03-03
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 (K981542)Panasonic Corporation (Panasonic)1999-03-03
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR (K984322)Dideco S.P.A.1999-03-02
ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL (K964235)Industrielle Entwicklung Medizintechnik Und Vertri1999-03-02
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES (K990106)Bio-Detek, Inc.1999-02-26
7F HYDROLYSER THROMBECTOMY CATHETER (K983534)Cordis Corp.1999-02-26
OASIS THROMBECTOMY CATHETER SYSTEM (K982363)Boston Scientific Corp1999-02-23
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER (K983471)Radi Medical Systems AB1999-02-23
(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700 (K990380)Meditec Co., Ltd.1999-02-22
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K984294)Intervascular, Inc.1999-02-22
PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER (K984150)Ep Medsystems1999-02-22
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM (K983314)Nycomed Amersham Imaging1999-02-19
E-FAX SYSTEM (K982034)Blakbag, Ltd., Division of Coherent Systems1999-02-19
BIPORE BALLOON DILATATION CATHETER (K983650)Bipore, Inc.1999-02-17
ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW (K984089)Zymed Medical Instrumentation1999-02-16
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) (K980723)Vascutech, Inc.1999-02-12
NEUROVASX SUB-MICROINFUSION CATHETER (K984258)Neuro Vasx, Inc.1999-02-11
ACIST INJECTOR SYSTEM, MODEL CL100 H (K984058)Acist Medical Systems1999-02-11
OMNICORDER, MODEL 464 (K990027)Del Mar Avionics1999-02-09
IQ SYSTEM (K981720)Renaissance Technology, Inc.1999-02-08
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II (K983626)Alaris Medical Systems, Inc.1999-02-05
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP (K983372)Sunscope Intl., Inc.1999-02-05
PRESSUREWIRE SENSOR, MODEL #12001 (K983506)Radi Medical Systems AB1999-02-03
EWC: ECG II CABLE LEADWIRE SYSTEM (K984263)Ewc1999-02-02
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA (K980631)Embol-X, Inc.1999-02-02
GUIDEWIRE (K982559)Galt Medical Corp.1999-02-01
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (K982385)Porous Media Corp.1999-02-01
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 (K984182)Possis Medical, Inc.1999-02-01
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (K984183)Possis Medical, Inc.1999-02-01
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K (K990125)Hewlett-Packard GmbH1999-01-29
VENOMETER (K983900)Advanced Medical Technology , Ltd.1999-01-29
MERCATOR (K982384)Harley Street Software , Ltd.1999-01-27
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, (K982540)Cardiac Pathways Corp.1999-01-27
AURORA (K972065)Neurovena Corp.1999-01-27
GT LEGGIERO (K981359)Terumo Medical Corp.1999-01-27
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) (K984260)Terumo Medical Corp.1999-01-26
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM (K982090)Paceart, Inc.1999-01-26
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 (K982264)Survivalink Corp.1999-01-25
6004 NIBP MONITOR WITH TEMPERATURE (K983796)Bci Intl., Inc.1999-01-22
MCAS (MODULAR CLIP APPLIER SYSTEM) (K983744)Applied Medical Resources1999-01-21
BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES (K983689)Medicotest A/S1999-01-15
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 (K982228)Tz Medical, Inc.1999-01-14
HEART-LIFT BALLOON POSITIONER (K982419)Cardiothoracic Systems, Inc.1999-01-13
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K984456)Cobe Cardiovascular, Inc.1999-01-11
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 (K982272)Biotronik, Inc.1999-01-08
LIDCO SYSTEM (K962918)Lidco, Ltd.1999-01-08
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M (K984435)Medtronic Vascular1999-01-07
HEWLETT-PACKARD M1205A VIRIDIA 24 CT (K981376)Hewlett-Packard Co.1999-01-04
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 (K983055)Guidant Corp.1998-12-30
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K984500)Cordis Corp.1998-12-23
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D (K983653)Cardiac Pathways Corp.1998-12-22
CS/3 COMPACT AIRWAY MODULE, M-COVX (K982091)Datex-Engstrom, Inc.1998-12-22
HEARTSTREAM ELECTRODE ADAPTER (K984286)Hewlett-Packard Co.1998-12-17
DISTAFLO BYPASS GRAFT (K983769)Impra, Inc.1998-12-15
MS-900S, MS-900SPM & MS-900SFM (K980845)Mars Medical Products1998-12-14
RTM DVT PROSOFT CUFF MODEL NUMBER PS100 (K981643)R.T. Medical Services, Inc.1998-12-14
SILVERSTREAK HYDROPHILIC GUIDEWIRE (K982543)Micro Therapeutics, Inc.1998-12-11
MEDTRONIC ANGIOGRAPHIC CATHETER (K980973)Medtronics Interventional Vascular1998-12-10
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 (K981737)Katecho, Inc.1998-12-09
NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C (K982728)Nellcor Puritan Bennett, Inc.1998-12-07
MONITOR ONE NDX (K972991)Qmed, Inc.1998-12-03
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 (K983026)Card Guard Scientific Survival , Ltd.1998-12-02
PERIPHERAL VASCULAR DILATOR (K974617)Endovascular Instruments, Inc.1998-12-01
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE (K974259)Edwards Lifesciences Research Medical1998-12-01
BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB (K982797)Luther Medical Products, Inc.1998-11-30
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (K982104)Medical Data Electronics1998-11-25
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 (K981802)Bio-Detek, Inc.1998-11-25
DISTAFLO BYPASS GRAFT (K983861)Impra, Inc.1998-11-24
TUBING BLOOD FLOW METER MODEL NUMBER HD-800 (K982986)Koven Technology, Inc.1998-11-24
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN (K983819)Intervascular, Inc.1998-11-24
BAXTER HEMOSTASIS VALVE INTRODUCERS (K981909)Baxter Edwards1998-11-24
URESIL VASCU-FLO INFUSION CATHETER (K980278)Uresil Corp.1998-11-20
MODIFICATION TO PORTABLE INTENSIVE CARE UNIT (K983307)Medical Research Laboratories, Inc.1998-11-20
IMPRA HIGH POROSITY GRAFT (K983064)Impra, Inc.1998-11-19
AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 (K982657)Microvena Corp.1998-11-18
FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F (K983855)Jawon Medical Co., Ltd.1998-11-17
CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (K980045)Invivo Research, Inc.1998-11-16
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS (K983980)Siemens Medical Solutions USA, Inc.1998-11-16
HEARTLINK, MODEL II (K982803)Cardiac Telecom Corp.1998-11-13
MEDI-TRACE 4103 NEONATAL ELECTRODE (K981964)Graphic Controls Corp.1998-11-13
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