meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
39
Latest Decision
1979-08-10

Clearances · page 186 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K791338 DUAL HEAD STETHOSCOPE Amdia Medical Products DQD Class II 1979-08-10
K791147 ARCO PROGAMMABLE PACEMAKER SYSTEM Arco Medical Products Co. DXY Class III 1979-08-03
K791363 KWIK-AWA VEST Medical Specialties, Inc. DRG Class II 1979-08-03
K791370 SILICONE SURGICAL VESSEL LOOPS Conphar, Inc. DWS Class I 1979-08-03
K791364 QUINTON MODEL 630 AND 636 ECG DATA CART Quinton, Inc. DPS Class II 1979-08-03
K790220 PACEMAKER PROGRAMMER Intermedics, Inc. KRG Class III 1979-07-31
K791159 DINAMAP MODEL 855 Applied Medical Research DXN Class II 1979-07-30
K790446 OVALITH-300 Coratomic, Inc. DXY Class III 1979-07-30
K791151 ECG CHANNEL OF DIAGNOSTIC SYSTEM Honeywell, Inc. DPS Class II 1979-07-30
K791219 UNILITH PULSE GENERATOR Ela Medical, Inc. DXY Class III 1979-07-30
K791276 PERVENOUS LEAD INTRODUCER SYSTEM Cordis Corp. DQX Class II 1979-07-24
K782162 BATTERY CHARGER, 171 PACEMAKER Telectronics, Inc. DXY Class III 1979-07-24
K782161 PULSE GENERATOR, MODEL 171 Telectronics, Inc. DXY Class III 1979-07-24
K791129 PERMANENT LEAD INTRADUCER Daig Corp. DYB Class II 1979-07-17
K791183 SWAN-GANZ FLOW-DIRECTED CATHETER Edwards Lifesciences, LLC LDF Class II 1979-07-12
K790983 BIFLEX TM TEMPORARY PACING PROBE Advanced Medical Concepts, Inc. DTB Class III 1979-07-10
K791145 CPR CONTROL SYSTEM Pepin Distributing, Inc. DRM Class II 1979-07-10
K791139 PREGELLED DISPOSABLE ECG ELECTRODES Hayes Products, Inc. DRX Class II 1979-07-10
K791054 HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC C.R. Bard, Inc. DXN Class II 1979-07-10
K791165 ARCOLITH 4000 Arco Medical Products Co. DXY Class III 1979-07-10
K791140 PREGELLED DISPOSABLE EELCTRO. SERIES 600 Hayes Products, Inc. DRX Class II 1979-07-10
K790429 MEDTRONIC MODEL 6957 Medtronic Vascular DTB Class III 1979-07-05
K790670 PULSE GENERATOR MODEL 629 Elema-Schonander, Inc. DXY Class III 1979-06-27
K790999 APOLLO HEART RATE INDICATOR Apollo Products, Inc. JOM Class II 1979-06-22
K791098 SINGLE-USE MINI-BULLDOG Med General DXC Class II 1979-06-22
K790835 DYNAJECT Atomic Products Corp. DXT Class II 1979-06-22
K791026 4F STERILE BALLOON-LESS, CATHETER 913-28 Waters Assoc., Inc. KRB Class II 1979-06-22
K791107 STOPCOCK, THREE WAY Norton Performance Plastics Corp. DTL Class II 1979-06-22
K791093 MODELS 2411/2418 VENTRICULAR-INHIBITED Medtronic Vascular DXY Class III 1979-06-20
K790938 SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO Shiley, Inc. DWP Class II 1979-06-13
K791006 SMART BILECTRODES Electronics For Medicine, Inc. DRX Class II 1979-06-11
K790988 MODEL 6971 W/ DBS WIRE Medtronic Vascular DTB Class III 1979-06-11
K790939 MODEL 78501A PATIENT MONITORING SYSTEM Hewlett-Packard Co. DPS Class II 1979-06-11
K790882 LEAD INTRODUCER SET Introstat DQX Class II 1979-06-11
K790838 ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) Shiley, Inc. DXE Class II 1979-06-11
K790756 HEAT EXCHANGER COIL Delta Medical Industries DTR Class II 1979-06-11
K790565 AORTIC ROOT CANNULA Dlp, Inc. DWF Class II 1979-06-11
K790545 STRESS TESTING SYSTEM, LATERAL TILTING Engineering Dynamics Corp. DRT Class II 1979-06-06
K790544 STRESS TESTING SYSTEM, MULTI-POSITION Engineering Dynamics Corp. DRT Class II 1979-06-05
K782018 LEADS, IMPLANTABLE CARDIAC PACEMAKERS Oscor, Inc. DTB Class III 1979-06-04
K791003 ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA Physio-Control Corp. DRX Class II 1979-06-01
K790757 LIFEPAK 5 MONITOR, CASSETTE, #800923-01 Physio-Control Corp. DSH Class II 1979-06-01
K790548 ENDOCARDIAL PACING LEAD, MODEL 476-01 Intermedics, Inc. DTB Class III 1979-06-01
K790666 VITALITH S 3000 SERIES Vitatron Medical BV DXY Class III 1979-06-01
K790476 QUICKSCAN HOLTER II Intl. Medical, Inc. DSH Class II 1979-06-01
K791002 ECG ELECTRODES, PEDIATRIC-FOAM TAPE Physio-Control Corp. DRX Class II 1979-06-01
K790794 SIEMENS CARDIOSTAT 701 Elmed, Inc. DPS Class II 1979-05-31
K790825 LS-8 VISICORDER Honeywell, Inc. DSF Class I 1979-05-31
K790867 CARDIAC PULSE GENERATOR, 16 SERIES Telectronics, Inc. DXY Class III 1979-05-31
K790513 HLA-2000 Bdt Ent. DRM Class II 1979-05-31
K790959 LIFEPATCH ECG ELECTRODES Physio-Control Corp. DRX Class II 1979-05-31
K790810 DISPOSA-CUF Crest Medical Equipment DXQ Class II 1979-05-25
K790804 PURGE LINE UNIT Surgikos, Inc. DTL Class II 1979-05-25
K790766 MEDTRONIC MODELS 6907/6901 Medtronic Vascular DTB Class III 1979-05-25
K790868 GENERATOR, 16 SERIES, MODIFIED TOP CAP Telectronics, Inc. DXY Class III 1979-05-25
K790668 VENOUS PRESSURE MONITOR, MF 35 LF Deco Medical, Inc. KRK Class II 1979-05-23
K790507 800 ECG ELECTRODE Simonsen & Weels Eftf. DRX Class II 1979-05-18
K790503 CARDIOTEST 2200 Cardiac Pacemakers, Inc. DTA Class II 1979-05-17
K790869 CARDIO-SLIDECOMP Creative Instruments DPS Class II 1979-05-17
K790407 MICROTEC BACTERIAL FILTER Medex, Inc. DRS Class II 1979-05-16
K790837 ARRHYTHMIA II CARDULE Spacelabs, Inc. DSI Class II 1979-05-16
K790690 OMNI-STANICOR-(THETA) MODEL 217 Cordis Corp. DXY Class III 1979-05-16
K790436 IMPLANTABLE HEART LEAD TERMINAL ADAPTER Arco Medical Products Co. DTD Class II 1979-05-14
K790546 FLOWMETER, OPTIFLO GAS Cobe Laboratories, Inc. DTX Class II 1979-05-11
K790562 PULSE GENERATOR MODEL 61 AND 128 Ela Medical, Inc. DXY Class III 1979-05-08
K790452 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS Edwards Pacemaker Systems DXY Class III 1979-05-08
K790537 AUTOMATIC ELECTRONIC SPHYMOMONOMETER Healthcare Enterprises, Inc. DXN Class II 1979-05-08
K790552 AS7 & AS8 MONITORS Narco Air-Shields DRT Class II 1979-05-01
K790730 NDM PAPER TAPE ECG ELECTRODE Ndm Corp. DRX Class II 1979-04-26
K790739 QUINTON MODEL 530X ECG DATA CART Quinton, Inc. DPS Class II 1979-04-26
K790644 SUBMAX Chase Mfg. Co. DRT Class II 1979-04-26
K790764 PACEMAKERS WITHOUT SILASTIC COATING Telectronics, Inc. DXY Class III 1979-04-26
K790635 Q220F CARDITOMY RESERVOIR/MODIFIED Bentley Laboratories, Inc. DTN Class II 1979-04-18
K790344 BIPOLAR PERNENOUS VENTRICULAR LEAD Cordis Corp. DTB Class III 1979-04-17
K790462 MEDTRONIC MODEL 6972 Medtronic Vascular DTB Class III 1979-04-16
K790691 25-50 EKG RULER Medical Engineering Designs Co., Inc. DPS Class II 1979-04-16
K790564 ADAPTER-STRAIGHT Dlp, Inc. DTL Class II 1979-04-12
K790563 ADAPTERS-Y-TYPE Dlp, Inc. DTL Class II 1979-04-12
K790506 DAISCOPE & ACCESSORIES Simonsen & Weels Eftf. DRT Class II 1979-04-09
K790450 NOVATEC PRM Novatec, Inc. JOM Class II 1979-04-06
K790386 LEAD MODELS MUM 1260, MUM 1290 Ela Medical, Inc. DTB Class III 1979-04-03
K790305 ELECTRODES, FERRIS ECG, TYPES 905,906 Ferris Mfg. Corp. DRX Class II 1979-04-03
K790454 MODEL 78801A PATIENT MONITORS Hewlett-Packard Co. DRT Class II 1979-04-03
K790074 MEDTRONIC MODEL 6971 Medtronic Vascular DTB Class III 1979-03-29
K790361 RECIRCULATION FILTER MODEL RF-10 Bentley Laboratories, Inc. KRJ Class II 1979-03-28
K790435 INTERSEPT* BLOOD FILTER W/ TUBING BYPASS Surgikos, Inc. DTM Class II 1979-03-27
K790300 META III Hittman Medical Systems DPS Class II 1979-03-27
K790534 MERSILENE SUTURES Hancock Laboratories, Inc. KRH Class II 1979-03-26
K790455 MICROFLUSH Medex, Inc. KRA Class II 1979-03-23
K790509 CARDIOCASSETTE II, AMBULATORY ECG SYSTEM Cambridge Instruments, Inc. DSH Class II 1979-03-23
K790394 DEFIBRILLATOR INTERAL PADDLE TEST LOAD Physio-Control Corp. DRL Class II 1979-03-23
K781973 CARDIOPHONE North American Motronic DXY Class III 1979-03-21
K790432 MICROLITH MODELS 505;605;507;607;703;803 Cardiac Pacemakers, Inc. DXY Class III 1979-03-20
K790468 IMPLANTABLE HEART LEAD EXTENDER Arco Medical Products Co. DTD Class II 1979-03-19
K790566 PACEMAKER, OVALITH-D CARDIAC Caratomic DXY Class III 1979-03-19
K790470 THE GUARDIAN SPHYGMOMANOMETER World Book Encyclopedia, Inc. DXN Class II 1979-03-16
K790109 TELEMETRY, BIOMEDICAL Lkc Technologies, Inc. DRG Class II 1979-03-16
K790277 QUICK-CHECK United States Surgical, A Division of Tyco Healthc DXN Class II 1979-03-16
K790356 OXYGENATOR, COBE CATALOG #42-220 Cobe Laboratories, Inc. DTZ Class II 1979-03-09
K790198 MONITOR PLUG-IN MODEL M1106 ECG Electronics For Medicine, Inc. DRT Class II 1979-03-06

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