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Cardiovascular

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

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RecordFirmDate
BUCHBINDER MULTIFLEX GUIDEWIRE (K884274)Medtronic Vascular1988-12-27
Q5000 ST/HR SLOPE MODIFICATION (K883468)Quinton, Inc.1988-12-27
USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR (K884104)C.R. Bard, Inc.1988-12-21
ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE (K884262)Advanced Cardiovascular Systems, Inc.1988-12-21
INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (K884390)Medtronic Blood Systems, Inc.1988-12-21
USCI DORROS INFUSION/PROBING CATHETER (K884209)Usci, Div. C.R. Bard, Inc.1988-12-21
BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET (K884129)Bio Medicus, Inc.1988-12-21
OXINET N-7500 PULSE OXIMETRY NETWORK (K884142)Nellcor, Inc.1988-12-16
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER (K884329)Baxter Healthcare Corp1988-12-16
MRL PACETTE, 450SLL (K880932)Medical Research Laboratories, Inc.1988-12-16
NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER (K883919)Naparima, Inc.1988-12-16
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (K884278)Telectronics, Inc.1988-12-15
CENTURY COLOR TRACE (K884152)Biomedical Systems, Inc.1988-12-15
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM (K884318)Abbott Laboratories1988-12-13
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE (K884198)Target Therapeutics1988-12-13
HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT (K882657)Harbor Medical Devices, Inc.1988-12-13
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS (K881841)Buckman Co., Inc.1988-12-13
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (K883888)Advanced Biosearch Assn.1988-12-12
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. (K882289)Aries Medical, Inc.1988-12-12
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F (K884394)Ela Medical, Inc.1988-12-08
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED (K884005)Medtronic Vascular1988-12-05
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS (K883723)Cook, Inc.1988-12-05
ENCOR UNIPOLAR VS-1 LEADS (K883070)Cordis Leads, Inc.1988-12-05
SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM (K883071)3M Health Care, Sarns1988-12-05
POLYCORD II (K880303)Technetics, Inc.1988-12-05
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS (K882414)Gish Biomedical, Inc.1988-12-05
INTERSEPT* PREBYPASS FILTER (K884244)Medtronic Blood Systems, Inc.1988-12-05
SYSTEM VI MONITOR (K874326)Air-Shields, Inc.1988-12-05
USCI TANDEM ADAPTER (K884200)C.R. Bard, Inc.1988-12-05
INTRODUCING CATHETER (K883933)Devices For Vascular Intervention, Inc.1988-12-02
EXCEL INFLATE-AID (K883769)Medical Profiles, Inc.1988-12-01
FLO-RESTER (K883696)Bio-Vascular, Inc.1988-11-30
TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER (K881303)Triton Technology, Inc.1988-11-29
TRANSESOPHAGEAL ECHO TRANSDUCER (K883889)General Electric Co.1988-11-29
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES (K882383)CIVCO Medical Instruments Co., Inc.1988-11-28
ULTRASONIC IMAGING CATHETER (K883202)Boston Scientific Corp1988-11-23
MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER (K883651)Millar Instruments, Inc.1988-11-18
TRIAD-EP II, PUSHBUTTON, CABLE INPUT (K884532)Cardiotronics, Inc.1988-11-18
TDK ECG ELECTRODE, MEL-10L (K883643)Tdk Corp.1988-11-17
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS (K883755)Medtronic Vascular1988-11-17
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 (K884215)Medtronic Vascular1988-11-17
MODEL 2331T PATIENT PROGRAMMER (K880738)Medtronic Vascular1988-11-17
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER (K884033)Biodynamics Corp.1988-11-17
LOGIC 3 ELECTROCARDIOGRAPH (K882472)Cel-Med Co., Inc.1988-11-17
TRIAD-EP II, PLATE INPUT (K884530)Cardiotronics, Inc.1988-11-17
MARQUETTE 1200 DEFIBRILLATOR (K882067)Marquette Electronics, Inc.1988-11-17
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 (K882391)Ela Medical, Inc.1988-11-14
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE (K883178)Cardiotronics, Inc.1988-11-09
MODEL 459 ELECTROCARDIOCORDER RECORDER (K884009)Del Mar Avionics1988-11-09
CARDIOBEEPER II (K883843)Survival Technology, Inc.1988-11-09
OEC-7102 ECG/NIBP MONITOR (K882254)Nihon Kohden America, Inc.1988-11-09
MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A (K883973)Nihon Kohden America, Inc.1988-11-09
SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY (K883930)Seamed Corp.1988-11-09
SENSOCOR(TM) R-TEST 240 XL (K881772)Sensormedix, Inc.1988-11-09
ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR (K882635)Nihon Seimitsu Sokki Co., Ltd.1988-11-09
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY (K883304)Cardiotronics, Inc.1988-11-09
ALCON FLUID INJECTOR (K882723)Alcon Laboratories1988-11-08
IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER (K882138)Imex Medical Systems, Inc.1988-11-07
OLV 1100; OLV 1200 PULSE OXIMETERS (K881307)Nihon Kohden America, Inc.1988-11-04
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES (K883923)Gish Biomedical, Inc.1988-11-04
CORONARY GUIDE WIRE (K883579)Datascope Corp.1988-11-04
TITANIUM GREENFIELD VENA CAVA FILTER CARRIER (K874096)Medi-Tech, Inc.1988-11-04
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES (K883564)Advanced Cardiovascular Systems, Inc.1988-11-03
VARITEST (K882547)Eureka AB1988-11-03
SYMBION CENTRIFUGAL BLOOD PUMP MODEL I (K882129)Symbion, Inc.1988-11-03
GUIDING CATHETER (TIP SOFTNESS CHANGE) (K883981)Devices For Vascular Intervention, Inc.1988-11-03
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) (K883603)3M Health Care, Sarns1988-11-03
PREDICTOR II SIGNAL AVERAGING ECG (K883855)Corazonix Corp.1988-11-03
Q4000 OPTION FOR Q4000 (K882978)Quinton, Inc.1988-11-01
PERMANENT PACING LEADS PYBJ SERIES (K882345)Oscor Medical Corp.1988-10-28
0.014 PERIPHERAL GUIDE WIRE (K882804)Intensive Technology, Inc.1988-10-28
3D VASCULAR RECORDER (K883908)D. E. Hokanson, Inc.1988-10-28
ROTATING HEMOSTATIC VALVE (K883916)Devices For Vascular Intervention, Inc.1988-10-28
PERMANENT PACING LEAD MODEL RXBJ SERIES (K882462)Oscor Medical Corp.1988-10-28
BIO-MEDICUS TUBING CONNECTORS (K883956)Bio Medicus, Inc.1988-10-28
BM-103 BATTERY MODULE (K883877)Datex Division Instrumentarium Corp.1988-10-28
KONTRON PULSE OXIMETER 7840 (K873624)Kontron Instruments, Inc.1988-10-19
CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS (K873772)Cordis Leads, Inc.1988-10-19
WILSON BIOMEDICAL CORONARY GUIDING CATHETER (K881793)Wilson Biomedical, Inc.1988-10-19
CARDIOMEGA-T (K883410)Grandcor Medical Systems1988-10-17
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER (K883436)Ppg Industries, Inc.1988-10-17
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER (K884023)Cardiac Control Systems, Inc.1988-10-17
MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD (K883265)Telectronics and Cordis Pacing Systems1988-10-14
AIR PLETHYSMOGRAPH MODEL APG-1000 (K881291)Aci Medical, Inc.1988-10-14
POLYSAFE(TM) IMPLANTABLE PACING LEAD (K884024)Cardiac Control Systems, Inc.1988-10-14
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE (K883174)Baxter Healthcare Corp1988-10-14
BLOOD PRESSURE CUFF (K881799)Biomedical Dynamics, Inc.1988-10-14
ACS INDEFLATOR P/T 20 (K883452)Advanced Cardiovascular Systems, Inc.1988-10-14
MEDTRONIC MODEL 4951P (K881810)Medtronic Vascular1988-10-13
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION (K882758)3M Health Care, Sarns1988-10-13
PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT (K883221)Pioneering Technologies, Inc.1988-10-13
EP-STAT (K883152)Coherent Systems, Inc.1988-10-13
INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM (K883439)Medtronic Blood Systems, Inc.1988-10-13
TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM (K883358)Telescan Medical Systems1988-10-13
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER (K873674)Shimadzu Corp.1988-10-07
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER (K883297)Hewlett-Packard Co.1988-10-06
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP (K883015)Cardiac Control Systems, Inc.1988-10-06
FIRST MEDIC MODE 610 (K883584)First Medical Devices Corp.1988-10-06
PACER SENSING ANALYZER (PSA 100) (K882327)Oscor Medical Corp.1988-10-06
BARD MULTI-TAC ECG MONITORING ELECTRODE (K884064)C.R. Bard, Inc.1988-10-06
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