meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1977-06-14

Clearances · page 191 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K770988 FOAM ECG ELECTRODE, 2060 AND 2061 Cardio-Dynamics Laboratories, Inc. DRX Class II 1977-06-14
K770977 CARDIOVASCULAR SPRING GUIDES Lake Region Mfg., Inc. DQX Class II 1977-06-14
K771014 TS-100 TEST SYSTEM Delta Medical Industries KRC Class II 1977-06-14
K770865 MONITOR, PACEMAKER Adcor Electronics, Inc. DTC Class II 1977-06-14
K771021 AUTO-CLIP Axiom Medical, Inc. DSS Class II 1977-06-14
K770839 AQUAMATIC K-77 Gorman Rupp Industries DWJ Class II 1977-06-08
K770832 PORTASCOPE II Mennen Greatbatch Electonics DPS Class II 1977-06-03
K770949 COMPUTER ECG TELE. TRANSMISSION TERMINAL The Okun Co. DXH Class II 1977-06-02
K770705 CARDIAC ACQUISITION SYSTEM, ICR 2001 Instruments For Cardiac Research DQK Class II 1977-06-02
K770921 SPHYGMOMANOMETER, ELECTRONIC Bristoline, Inc. DXN Class II 1977-06-02
K770884 ELHCTROCARDIOGRAPHIC CONNECTING WIRES Tronomed, Inc. DSA Class II 1977-05-23
K770755 ECHOCARDIOGRAPHY SYS., MODEL 3830 Honeywell, Inc. DXK Class II 1977-05-09
K770757 PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 Honeywell, Inc. DQC Class I 1977-05-09
K770756 ECHOCARDIOGRAPHY SYS., MODEL 3860 Honeywell, Inc. DXK Class II 1977-05-09
K770760 MONITOR, PORTABLE, PATIENT, G.E. General Electric Co. DPS Class II 1977-05-06
K770821 PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT Avco Medical Products DSP Class II 1977-05-06
K770709 PROBE, TEMPERATURE, SYSTEM, SARNS 3M Health Care, Sarns DRF Class II 1977-04-27
K770714 CATHETER, ARTERIAL EMBOLECTOMY Mallinckrodt Critical Care DXE Class II 1977-04-27
K770716 GENERATOR, PULSE, UNIPOLAR, MODEL #504 Cardiac Pacemakers, Inc. DXY Class III 1977-04-26
K770681 VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR Scimed Life Systems, Inc. KRI Class I 1977-04-26
K770656 GENERATOR, PULSE, CARDIAC 20U Edwards Pacemaker Systems DXY Class III 1977-04-26
K770657 GENERATOR, PULSE, CARDIAC 2LU Edwards Pacemaker Systems DXY Class III 1977-04-26
K770661 GENERATOR, PULSE, IMPLANTABLE Med Telectronics , Ltd. DXY Class III 1977-04-26
K770675 COMPUTER, CARDIAC OUTPUT, MODEL KM275 Lexington Instruments DXG Class II 1977-04-26
K770561 CATHETER,PERCUTANEOUS INTRODUC. & SHEATH Usci, Div. C.R. Bard, Inc. DYB Class II 1977-04-26
K770546 BLOOD RESERVOIR Delta Medical Industries DTN Class II 1977-04-26
K770715 GENERATOR, PULSE, BIPOLAR, MODEL #604 Cardiac Pacemakers, Inc. DXY Class III 1977-04-25
K770507 PULSE GENERATOR, LITKICRON MODEL 3-70H Medcor, Inc. DXY Class III 1977-04-07
K770468 UNIPOLAR LEAD CONFIGURATION CONDUCTOR Daig Corp. DTB Class III 1977-04-05
K770569 CATHETER, EMBOLECTOMY, UMI Universal Medical Instrument Corp. DXE Class II 1977-04-05
K770179 CARDIAC CATHETERIZATION LAB MONITOR SYS General Electric Co. DXG Class II 1977-04-05
K770419 CENTURION Johnson & Johnson Professionals, Inc. DXY Class III 1977-04-05
K770478 ADAPTER, CORDIS Cordis Corp. DTD Class II 1977-03-30
K770477 CITADEL REFERENCE ELECTRODE Sherwood Medical Industries DRF Class II 1977-03-30
K770503 LOUISVILLE CLAMP PRODUCT #65-172 Edward Weck, Inc. DXC Class II 1977-03-30
K770512 CANNULA, INTRAVENOUS, R Sherwood Medical Industries DQR Class II 1977-03-30
K770522 CATHETER, GRUNTZIG, BALLON Cook, Inc. DYG Class II 1977-03-30
K770521 ELECTROCARDIOGRAPHIC ELECTRODES, DISP. Dobre, Inc. DRX Class II 1977-03-29
K770214 TEMP. PERVENOUS LEAD W/REMOTE ANODE Cordis Corp. DTB Class III 1977-03-28
K770559 C-L0L CARDIAC PACEMAKER Coratomic, Inc. DXY Class III 1977-03-28
K770430 CATHETER, CURVED LEFT HEART VENT 3M Health Care, Sarns DWF Class II 1977-03-16
K770429 CANNULAE, AORTIC, ARCH, HIGH FLOW 3M Health Care, Sarns DWF Class II 1977-03-16
K770404 OBTURATOR Abbott Laboratories DRB Class II 1977-03-16
K770431 CATHETER, TWO STAGE VENOUS RETURN 3M Health Care, Sarns DWF Class II 1977-03-16
K770427 CATHETER INTRODUCER KIT Electro-Catheter Corp. DYB Class II 1977-03-16
K770432 MICROFLUSH Medex, Inc. KRA Class II 1977-03-16
K770290 MONITORING KIT, CENTRAL VENOUS PRESSURE Argon Medical Corp. DQO Class II 1977-03-15
K770462 PUNCTURE KIT, INTERNAL JUGULAR Arrow Intl., Inc. DQO Class II 1977-03-14
K770416 LEAD, HEART, BUTTERFLY CLAMP Arco Medical Products Co. DTB Class III 1977-03-10
K770212 PROLITH MODEL 21S CARDIAC PULSE GEN. Edwards Pacemaker Systems DXY Class III 1977-03-09
K770002 CONSOLE, MOBILE FOR 3 PUMPS W/MASTS Cobe Laboratories, Inc. DTQ Class II 1977-03-07
K770211 MICROPULSE MODEL 20S Edwards Pacemaker Systems DXY Class III 1977-03-07
K770068 CANNULA, HUNTER-SESSIONS, SELF-RETAIN. Barlow Mfg., Corp. DWF Class II 1977-03-01
K770342 RECORDER, CHART, MODEL 5536 Hudson Oxygen Therapy Sales Co. DSF Class I 1977-03-01
K770366 ISOLATED ELECTROCARDIOGRAPH MODEL 1207 Electronics For Medicine, Inc. DPS Class II 1977-03-01
K770357 SPHYGMOMANOMETER, ELECTRONIC Ishimoto Trading Co. DXN Class II 1977-03-01
K770024 MONITOR, NEONATAL, MODEL 78260A Hewlett-Packard Co. DRT Class II 1977-02-28
K770023 MONITOR, NEONATE, MODEL 78213A Hewlett-Packard Co. DRT Class II 1977-02-28
K770341 TEMP. PROBE, & ELECTRONIC THERMOMETER Electro-Catheter Corp. DRF Class II 1977-02-28
K760368 MONITORING & STRESS TESTING EQUIPMENT Advanced Medical, Inc. DSI Class II 1977-02-28
K770022 MONITOR, NEONATAL, MODEL 78261A Hewlett-Packard Co. DRT Class II 1977-02-28
K770328 PACEMAKER, ANTRIO-VENTRICULAR SEQ. American Pacemaker Corp. DXY Class III 1977-02-28
K770236 SAUVAGE FILAMENTOUS PROSTHESES Usci, Div. C.R. Bard, Inc. DSY Class II 1977-02-25
K770282 WEDGE TIP, SMALL, MODEL #030-191 Med Telectronics , Ltd. DTB Class III 1977-02-24
K770285 BALL TIP, MODEL #030-188 Med Telectronics , Ltd. DTB Class III 1977-02-24
K770284 BALL TIP, MODEL #030-185 Med Telectronics , Ltd. DTB Class III 1977-02-24
K770332 AMPLIFIER, PHOTOPULSE, MODEL PA13 Medsonics JOM Class II 1977-02-24
K770279 MONITOR, PORTABLE, PART #431-010 Mennen Greatbatch Electonics DXJ Class II 1977-02-24
K770005 PACEMAKER 208S Elema-Schonander, Inc. DXY Class III 1977-02-24
K770283 WEDGE TIP, SMALL, MODEL #030-194 Med Telectronics , Ltd. DTB Class III 1977-02-24
K770330 MONITOR, PULSE WAVE VELOCITY P607 Cyborg Corp. DXG Class II 1977-02-24
K770235 DEBAKEY VASCULOUR-D PROSTHESES Usci, Div. C.R. Bard, Inc. DSY Class II 1977-02-24
K770264 PACEGUARD Cardio Data DXH Class II 1977-02-16
K770247 D.C. AMPLIFIER MODULE Mennen Greatbatch Electonics DRQ Class II 1977-02-14
K770243 ELGILOY STYLET Cardiac Pacemakers, Inc. DRR Class II 1977-02-14
K770239 DIGITAL HEART RATE METER Burdick Corp. DRT Class II 1977-02-14
K770199 LEAD EXTENDER MODEL 6516 Cardiac Pacemakers, Inc. DTD Class II 1977-02-07
K770135 LEAD MODIFICATION Elema-Schonander, Inc. DXY Class III 1977-02-07
K770197 UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR Cardiac Pacemakers, Inc. DXY Class III 1977-02-07
K770198 BIPOLAR ASYNCHRONOUS PULSE GENERATOR Cardiac Pacemakers, Inc. DXY Class III 1977-02-07
K770195 PERM. IMPLANT. ENDOCARDIAL PAC. LEAD Daig Corp. DTB Class III 1977-02-07
K770115 ARTERIAL DIAGNOSTIC UNIT (ADU) Medical Electronic Devices, Inc. DPW Class II 1977-02-01
K770083 LIFEPATCH TM ECG ELECTRODE Physio-Control Corp. DRX Class II 1977-02-01
K761328 ANASTOMASIS OCCLUDER Medical Engineering Corp. DWS Class I 1977-02-01
K761023 SIMULATOR, 10 LEAD ECG Birtcher Corp. DPS Class II 1977-01-31
K760857 TR-3 TRANSMITTER Burdick Corp. DXH Class II 1977-01-28
K770073 PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. Rohe Scientific Corp. DXK Class II 1977-01-25
K760738 AUTOMATIC ELECTRONIC SPHYGMOMANOMETER Medical Monitors, Inc. DXN Class II 1977-01-21
K770036 CARDIOTOMY RESERVOIR Shiley, Inc. DTN Class II 1977-01-14
K770017 PACING KIT, TRANSMYOCARDIAL Electro-Catheter Corp. DTR Class II 1977-01-14
K770037 ELECTROCARDIOGRAPH MODEL 344 Birtcher Corp. DPS Class II 1977-01-14
K770038 MONITOR, HEARTWATCH HEART RATE Respironics, Inc. DRT Class II 1977-01-14
K770016 PACING KIT, ELECATH TRANSTHORACIC Electro-Catheter Corp. DTR Class II 1977-01-14
K770018 PACING KIT, SEMI-FLOATING Electro-Catheter Corp. DTR Class II 1977-01-14
K770042 ADAPTER, LEAD, GENERAL ELECTRIC Cardiac Pacemakers, Inc. DTD Class II 1977-01-12
K761273 FLUSHFLO-MODEL CC1-6 Bentley Laboratories, Inc. KRA Class II 1977-01-12
K761318 3038 OPTION B-COMPUT. TRANS. TERMINAL Cambridge Instruments, Inc. DXH Class II 1977-01-06
K761325 MODEL DA-53 PRESSURE GUAGE ISOLATOR Extracorporeal Medical Specialities, Inc. DRS Class II 1977-01-06
K761274 BLOOD PRESSURE KIT, WELL-BE 669 Pearlduck, Inc. DXN Class II 1977-01-05
K760516 FELT, SURGICAL DACRON Meadox Medicals, Div. Boston Scientific Corp. DXZ Class II 1977-01-05

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