meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1988-12-05

Clearances · page 146 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K884005 ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED Medtronic Vascular DTB Class III 1988-12-05
K884200 USCI TANDEM ADAPTER C.R. Bard, Inc. DTL Class II 1988-12-05
K874326 SYSTEM VI MONITOR Air-Shields, Inc. DPS Class II 1988-12-05
K883723 FLEXIBLE MYOCARDIAL BIOPSY FORCEPS Cook, Inc. DWZ Class II 1988-12-05
K882414 BLOOD RESERVOIR, CARDIOPULMONARY BYPASS Gish Biomedical, Inc. DTN Class II 1988-12-05
K883071 SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM 3M Health Care, Sarns DTR Class II 1988-12-05
K880303 POLYCORD II Technetics, Inc. DSH Class II 1988-12-05
K883933 INTRODUCING CATHETER Devices For Vascular Intervention, Inc. DYB Class II 1988-12-02
K883769 EXCEL INFLATE-AID Medical Profiles, Inc. DXT Class II 1988-12-01
K883696 FLO-RESTER Bio-Vascular, Inc. DXC Class II 1988-11-30
K881303 TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER Triton Technology, Inc. DPT Class II 1988-11-29
K883889 TRANSESOPHAGEAL ECHO TRANSDUCER General Electric Co. JOP Class II 1988-11-29
K882383 MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES CIVCO Medical Instruments Co., Inc. DWZ Class II 1988-11-28
K883202 ULTRASONIC IMAGING CATHETER Boston Scientific Corp DXO Class II 1988-11-23
K883651 MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER Millar Instruments, Inc. DQO Class II 1988-11-18
K884532 TRIAD-EP II, PUSHBUTTON, CABLE INPUT Cardiotronics, Inc. DRO Class II 1988-11-18
K884033 BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER Biodynamics Corp. DSB Class II 1988-11-17
K882472 LOGIC 3 ELECTROCARDIOGRAPH Cel-Med Co., Inc. DPS Class II 1988-11-17
K883643 TDK ECG ELECTRODE, MEL-10L Tdk Corp. DRX Class II 1988-11-17
K884215 MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 Medtronic Vascular DXY Class III 1988-11-17
K880738 MODEL 2331T PATIENT PROGRAMMER Medtronic Vascular KRG Class III 1988-11-17
K884530 TRIAD-EP II, PLATE INPUT Cardiotronics, Inc. DRO Class II 1988-11-17
K883755 MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS Medtronic Vascular DXY Class III 1988-11-17
K882067 MARQUETTE 1200 DEFIBRILLATOR Marquette Electronics, Inc. MKJ Class III 1988-11-17
K882391 OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 Ela Medical, Inc. DXY Class III 1988-11-14
K883930 SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY Seamed Corp. DTE Class II 1988-11-09
K882254 OEC-7102 ECG/NIBP MONITOR Nihon Kohden America, Inc. DPS Class II 1988-11-09
K883178 TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE Cardiotronics, Inc. DRO Class II 1988-11-09
K884009 MODEL 459 ELECTROCARDIOCORDER RECORDER Del Mar Avionics DSH Class II 1988-11-09
K882635 ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1988-11-09
K883843 CARDIOBEEPER II Survival Technology, Inc. DXH Class II 1988-11-09
K881772 SENSOCOR(TM) R-TEST 240 XL Sensormedix, Inc. DXH Class II 1988-11-09
K883973 MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A Nihon Kohden America, Inc. DXJ Class II 1988-11-09
K883304 TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY Cardiotronics, Inc. DRO Class II 1988-11-09
K882723 ALCON FLUID INJECTOR Alcon Laboratories DQF Class II 1988-11-08
K882138 IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER Imex Medical Systems, Inc. DPW Class II 1988-11-07
K883923 CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES Gish Biomedical, Inc. DTN Class II 1988-11-04
K874096 TITANIUM GREENFIELD VENA CAVA FILTER CARRIER Medi-Tech, Inc. DTK Class II 1988-11-04
K883579 CORONARY GUIDE WIRE Datascope Corp. DQX Class II 1988-11-04
K881307 OLV 1100; OLV 1200 PULSE OXIMETERS Nihon Kohden America, Inc. DQA Class II 1988-11-04
K883981 GUIDING CATHETER (TIP SOFTNESS CHANGE) Devices For Vascular Intervention, Inc. DWF Class II 1988-11-03
K882547 VARITEST Eureka AB JOM Class II 1988-11-03
K882129 SYMBION CENTRIFUGAL BLOOD PUMP MODEL I Symbion, Inc. KFM Class II 1988-11-03
K883603 SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) 3M Health Care, Sarns DWC Class II 1988-11-03
K883855 PREDICTOR II SIGNAL AVERAGING ECG Corazonix Corp. DXG Class II 1988-11-03
K883564 ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES Advanced Cardiovascular Systems, Inc. DQY Class II 1988-11-03
K882978 Q4000 OPTION FOR Q4000 Quinton, Inc. DSI Class II 1988-11-01
K883916 ROTATING HEMOSTATIC VALVE Devices For Vascular Intervention, Inc. DQY Class II 1988-10-28
K882462 PERMANENT PACING LEAD MODEL RXBJ SERIES Oscor Medical Corp. DTB Class III 1988-10-28
K882804 0.014 PERIPHERAL GUIDE WIRE Intensive Technology, Inc. DQX Class II 1988-10-28
K883956 BIO-MEDICUS TUBING CONNECTORS Bio Medicus, Inc. DTL Class II 1988-10-28
K883908 3D VASCULAR RECORDER D. E. Hokanson, Inc. JOM Class II 1988-10-28
K882345 PERMANENT PACING LEADS PYBJ SERIES Oscor Medical Corp. DTB Class III 1988-10-28
K883877 BM-103 BATTERY MODULE Datex Division Instrumentarium Corp. DQA Class II 1988-10-28
K873772 CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS Cordis Leads, Inc. DTB Class III 1988-10-19
K873624 KONTRON PULSE OXIMETER 7840 Kontron Instruments, Inc. DQA Class II 1988-10-19
K881793 WILSON BIOMEDICAL CORONARY GUIDING CATHETER Wilson Biomedical, Inc. DQY Class II 1988-10-19
K883410 CARDIOMEGA-T Grandcor Medical Systems DSI Class II 1988-10-17
K883436 PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER Ppg Industries, Inc. DXO Class II 1988-10-17
K884023 MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER Cardiac Control Systems, Inc. DXY Class III 1988-10-17
K881799 BLOOD PRESSURE CUFF Biomedical Dynamics, Inc. DXQ Class II 1988-10-14
K884024 POLYSAFE(TM) IMPLANTABLE PACING LEAD Cardiac Control Systems, Inc. DTB Class III 1988-10-14
K883452 ACS INDEFLATOR P/T 20 Advanced Cardiovascular Systems, Inc. DXT Class II 1988-10-14
K883174 MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE Baxter Healthcare Corp DQY Class II 1988-10-14
K881291 AIR PLETHYSMOGRAPH MODEL APG-1000 Aci Medical, Inc. DSB Class II 1988-10-14
K883265 MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD Telectronics and Cordis Pacing Systems DTB Class III 1988-10-14
K882758 CENTRIFUGAL PUMP SYSTEM LX/DX VERSION 3M Health Care, Sarns KFM Class II 1988-10-13
K883221 PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT Pioneering Technologies, Inc. DWF Class II 1988-10-13
K883439 INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM Medtronic Blood Systems, Inc. DTR Class II 1988-10-13
K883358 TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM Telescan Medical Systems DXH Class II 1988-10-13
K883152 EP-STAT Coherent Systems, Inc. DQK Class II 1988-10-13
K881810 MEDTRONIC MODEL 4951P Medtronic Vascular DTB Class III 1988-10-13
K873674 SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER Shimadzu Corp. JOP Class II 1988-10-07
K883297 HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER Hewlett-Packard Co. DQA Class II 1988-10-06
K883584 FIRST MEDIC MODE 610 First Medical Devices Corp. MKJ Class III 1988-10-06
K882327 PACER SENSING ANALYZER (PSA 100) Oscor Medical Corp. DTC Class II 1988-10-06
K883015 POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP Cardiac Control Systems, Inc. DTB Class III 1988-10-06
K882380 SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR Scimed Life Systems, Inc. DTN Class II 1988-10-06
K880599 POCKET MANOMETER Abbott Laboratories DXN Class II 1988-10-06
K883051 USCI SOFT-TIP ANGIOGRAPHIC CATHETER C.R. Bard, Inc. DQO Class II 1988-10-06
K884064 BARD MULTI-TAC ECG MONITORING ELECTRODE C.R. Bard, Inc. DRX Class II 1988-10-06
K883523 TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE Cardiotronics, Inc. DRO Class II 1988-10-06
K882235 POLY-TAC Cardiovascular Group, Inc. LDD Class II 1988-10-05
K882904 TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5 Tdk Corp. DRX Class II 1988-10-05
K881966 ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER C.R. Bard, Inc. DRF Class II 1988-10-04
K881825 MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH Spectramed, Inc. DYB Class II 1988-09-28
K881780 VASCUCARE ANGIOPUMP Vascucare, Inc. DWB Class II 1988-09-28
K882925 ACS SCHWARTEN XT BALLOON DILATATION CATHETER Advanced Cardiovascular Systems, Inc. LIT Class II 1988-09-28
K883345 SARNS INFANT VENOUS RESERVOIR MODEL #16387 3M Health Care, Sarns DTN Class II 1988-09-28
K882771 EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER Cook, Inc. DWF Class II 1988-09-27
K882981 PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP Pioneering Technologies, Inc. DWS Class I 1988-09-27
K882928 TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1988-09-27
K882892 MEMBRANE OXYGENATOR Baxter Bentley Laboratories, Inc. DTZ Class II 1988-09-27
K880756 MODEL PM-20A PHYSIOLOGICAL MONITOR Advanced Medical Systems, Inc. DQA Class II 1988-09-27
K883330 BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 Shiley, Inc. DTR Class II 1988-09-26
K883331 BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 Shiley, Inc. DTR Class II 1988-09-26
K883346 SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F Devices For Vascular Intervention, Inc. LIT Class II 1988-09-26
K881851 VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER Micro Medical, Ltd. DSB Class II 1988-09-26
K881632 FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT Huntleigh Technology, Inc. JOW Class II 1988-09-26
K883054 SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II Scimed Life Systems, Inc. DTZ Class II 1988-09-26

19,212 clearances in the Cardiovascular panel. Data: openFDA.