Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 40
- Latest Decision
- 1977-01-05
Clearances · page 192 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K761302 | ELECTRONIC BLOOD PRESSURE UNIT | Medline Industries, Inc. | DXN | Class II | 1977-01-05 |
| K761301 | V-TRACE ECG BACKPAD | Ndm Corp. | DRX | Class II | 1977-01-05 |
| K761077 | TREND ANALYZER | Eldeco | DSF | Class I | 1976-12-28 |
| K761074 | DYNAMIC RECORDER (DR-10) | Eldeco | DSH | Class II | 1976-12-28 |
| K761073 | POCKET TRANSMITTER (PT-10) | Eldeco | DXH | Class II | 1976-12-28 |
| K761288 | P-1 ULTRASONIC ARTERIOGRAPH | D. Eugene Hokanson | DPW | Class II | 1976-12-28 |
| K761291 | CENTRAL STATION MONITORING SYSTEM | Abbott Laboratories | DRT | Class II | 1976-12-28 |
| K761076 | DEMODULATOR/CARDIOTACHOMETER | Eldeco | DRT | Class II | 1976-12-28 |
| K761143 | LITHIUM IODIDE BATTERY PACEMAKER (#201) | Pacesetter Systems | DXY | Class III | 1976-12-23 |
| K761237 | ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 | Arco Medical Products Co. | DXY | Class III | 1976-12-21 |
| K761210 | LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) | Physio-Control Corp. | DRW | Class II | 1976-12-21 |
| K761249 | RADIO TRANSPARENT ECG ELECTRODE | Concept, Inc. | DRX | Class II | 1976-12-21 |
| K760714 | ENDO-LOK L-40 ENDOCARDIAL PACING ELECT. | Coratomic, Inc. | DTB | Class III | 1976-12-14 |
| K761211 | MODEL 15050A DIGITAL DISPLAY | Hewlett-Packard Co. | DRT | Class II | 1976-12-13 |
| K761031 | ELECATH ARTERIAL EMBOLECTOMY CATHETER | Electro-Catheter Corp. | DXE | Class II | 1976-12-13 |
| K760944 | ANGIOGRAPHIC GUIDEWIRE | Medrad, Inc. | DQX | Class II | 1976-12-10 |
| K761056 | DISPLAY MONITOR (MODEL 78301A) | Hewlett-Packard Co. | DRR | Class II | 1976-12-09 |
| K761169 | GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP | Pilling Co. | DXC | Class II | 1976-12-09 |
| K760884 | MICRO-COMPUTER ARRHYTHONIA SYSTEM | Spacelabs, Inc. | DSI | Class II | 1976-12-09 |
| K760894 | VACUUM RELIEF VALVE | Delta Medical Industries | DWD | Class II | 1976-12-09 |
| K761066 | ECG MONITOR (TELEPHONE ECG TRANSMITTER) | Physio-Control Corp. | DXH | Class II | 1976-12-09 |
| K761057 | ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) | Roche Medical Electronics, Inc. | DXN | Class II | 1976-12-09 |
| K761166 | TC-1 CARDIAC OUTPUT COMPUTER | Waters Assoc., Inc. | DXG | Class II | 1976-12-09 |
| K761194 | HLR QUICK-FIT HEART-LUNG RESUSCITATOR | Mckesson Corp. | DRM | Class II | 1976-12-09 |
| K761198 | MODEL 3044 3-CHANNEL STRESS TEST SYSTEM | Cambridge Instruments, Inc. | DPS | Class II | 1976-12-09 |
| K761055 | CALCULATOR PLOTTER (MODEL 9872A) | Hewlett-Packard Co. | DSF | Class I | 1976-12-09 |
| K761087 | ELECTRONIC CONTROL UNIT | Gorman Rupp Industries | DWJ | Class II | 1976-12-06 |
| K761014 | CARDIART 108T/313 | Conway Electronic Enterprises , Ltd. | DPS | Class II | 1976-12-06 |
| K761161 | 67-8006 DARLING-LINTON AORTIC TOURN. | Codman & Shurtleff, Inc. | DWS | Class I | 1976-12-06 |
| K760710 | PULSAR PULSE MONITOR WATCH | Time Computer, Inc. (Tci) | DRT | Class II | 1976-12-02 |
| K760271 | ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS) | Burdick Corp. | DPS | Class II | 1976-11-15 |
| K761017 | PRESSURE MODULE (MODEL P3) | Datascope Corp. | DRQ | Class II | 1976-11-15 |
| K760843 | PALEY TRANSPARENT MANIFOLD | Usci, Div. C.R. Bard, Inc. | DTL | Class II | 1976-11-12 |
| K760844 | CARDIAC OUTPUT COMPUTER (MODEL COC-100) | B-D Electrodyne | DXG | Class II | 1976-11-12 |
| K760670 | PACEMAKERS, VITATRONS (SERIES 2000) | Vitatron Medical BV | DXY | Class III | 1976-11-12 |
| K760824 | TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I | Travenol Laboratories, S.A. | DTZ | Class II | 1976-11-12 |
| K760671 | PACEMAKERS, VITATRONS (SERIES 3000) | Vitatron Medical BV | DXY | Class III | 1976-11-12 |
| K760669 | PACEMAKERS, VITATRON'S | Vitatron Medical BV | DXY | Class III | 1976-11-12 |
| K760272 | CIRCUIT, PRINTED, SERVO-MECHANISM | Burdick Corp. | DPS | Class II | 1976-11-12 |
| K760854 | THREE-CHANNEL STRESS TEST SYSTEM (M633) | Quinton, Inc. | DPS | Class II | 1976-11-12 |
| K760268 | ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC. | Burdick Corp. | DPS | Class II | 1976-11-12 |
| K760823 | TMO OXYGENATOR RESERVOIR PUMP SET | Travenol Laboratories, S.A. | DTN | Class II | 1976-11-12 |
| K760757 | MODEL 100 CARDIAC PACEMAKER | Pacesetter Systems | DXY | Class III | 1976-11-11 |
| K760791 | COOLEY ANGLED SCISSOR - 1MM PROBE POINT | V. Mueller O.V. Baxter Healthcare Corp. | DWS | Class I | 1976-11-11 |
| K760792 | SCISSOR - 1.5MM PROBE POINT, ANGLED | V. Mueller O.V. Baxter Healthcare Corp. | DWS | Class I | 1976-11-11 |
| K760926 | ELECTROCARDIOGRAPH (MODEL VS-4B) | Cambridge Instruments, Inc. | DPS | Class II | 1976-11-09 |
| K760930 | BLOOD PRESSURE & PULSE CHECKER | Bio Mega Diagnostic, Inc. | DXN | Class II | 1976-11-09 |
| K760386 | CENTRAL VEINOUS PRESSURE SETS | B. Braun Instruments | DQO | Class II | 1976-11-02 |
| K760388 | CATHETER, VEIN (VENOFIX) | B. Braun Instruments | DQO | Class II | 1976-11-02 |
| K760387 | CATHETER, CAVA (CAVAFIX) | B. Braun Instruments | DQO | Class II | 1976-11-02 |
| K760803 | PHYSIOLOGICAL MONITOR (MODEL 870) | Datascope Corp. | DRT | Class II | 1976-10-20 |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | Winn Hirsch & Assoc. | DTB | Class III | 1976-10-15 |
| K760756 | BATTERY OPERATED FLOW RATE COMPUTER | 3M Health Care, Sarns | DXG | Class II | 1976-10-15 |
| K760600 | CARDIAC OUTPUT COMPUTER | Cardiopulmonary Instrumentation | DXG | Class II | 1976-10-15 |
| K760676 | LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE | Physio-Control Corp. | DSF | Class I | 1976-10-13 |
| K760774 | TIME-SHARING MULTIPLEXER (MODEL 78308A) | Hewlett-Packard Co. | DXG | Class II | 1976-10-13 |
| K760751 | CONTINUOUS WAVE DOPPLER | Medsonics | DPW | Class II | 1976-10-13 |
| K760266 | MONITOR, ELECTROCARDIOSCOPE | Burdick Corp. | DPS | Class II | 1976-10-13 |
| K760767 | MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM | Honeywell, Inc. | DQK | Class II | 1976-10-13 |
| K760643 | MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N | Bd Becton Dickinson Vacutainer Systems Preanalytic | IZQ | Class II | 1976-10-08 |
| K760641 | MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N | Bd Becton Dickinson Vacutainer Systems Preanalytic | IZQ | Class II | 1976-10-08 |
| K760695 | TAMARI-KAPLITT | Yehuda Tamari | DSP | Class II | 1976-10-06 |
| K760721 | MEDICAL OSCILLOSCOPE MEMORY SCOPE | Abbott Laboratories | DXJ | Class II | 1976-10-06 |
| K760655 | ANEROID SPHYGMOMANOMETER | Abco Dealers, Inc. | DXQ | Class II | 1976-10-05 |
| K760677 | LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5) | Physio-Control Corp. | DPS | Class II | 1976-10-05 |
| K760645 | CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP | Pilling Co. | DWS | Class I | 1976-09-21 |
| K760612 | SPACELABS SERIES 1000 | Spacelabs, Inc. | DPS | Class II | 1976-09-21 |
| K760646 | CAROTID ARTERY CLAMP W/PILLING LMM | Pilling Co. | DWS | Class I | 1976-09-21 |
| K760648 | TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS | Pilling Co. | DWS | Class I | 1976-09-21 |
| K760624 | SMALL VESSEL CANNULA | Cobe Laboratories, Inc. | DWS | Class I | 1976-09-17 |
| K760593 | PORTABLE CARDIAC MONITOR, ABBY | Abbott Laboratories | DRT | Class II | 1976-09-16 |
| K760563 | ECG MODULATOR | Physio-Control Corp. | DXH | Class II | 1976-09-10 |
| K760564 | DEMODULATOR SERIES 1400 | Physio-Control Corp. | DXH | Class II | 1976-09-10 |
| K760539 | RECORDER (#78640A) | Hewlett-Packard Co. | DSF | Class I | 1976-09-09 |
| K760532 | COMPUTER, CARDIAC OUTPUT (#SP1425) | Gould, Inc. | DXG | Class II | 1976-09-09 |
| K760542 | ELECTROCARDIOGRAPH (#1505A) | Hewlett-Packard Co. | DPS | Class II | 1976-09-09 |
| K760533 | CATHETER, FLOW DIRECTED THERMAL DILUTION | Gould, Inc. | DYG | Class II | 1976-09-09 |
| K760523 | MONITOR SCOPE | Hewlett-Packard Co. | DXJ | Class II | 1976-09-03 |
| K760500 | TUBE, HEAVY GLASS WALL INJECTION | Unimetrics Corp. | DXL | Class II | 1976-09-03 |
| K760465 | STRESS SYSTEM, 3-CHANNEL (#21127A) | Hewlett-Packard Co. | DPS | Class II | 1976-08-30 |
| K760510 | MONITORING SYSTEM, REHABILITATION | Medcraft Corp. | DPS | Class II | 1976-08-30 |
| K760464 | PHON/STRESS SYSTEM (#21126A) | Hewlett-Packard Co. | DQC | Class I | 1976-08-30 |
| K760463 | STRESS SYSTEM, SINGLE-CHANNEL (#21125) | Hewlett-Packard Co. | DPS | Class II | 1976-08-30 |
| K760508 | ACCUTAPE 24 | Medcraft Corp. | DSH | Class II | 1976-08-30 |
| K760448 | SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT | Instrumentation Laboratory CO | DXL | Class II | 1976-08-27 |
| K760504 | PLETHYSMOGRAPH (MDI SYSTEM II) | Marketing Development Intl. | JOM | Class II | 1976-08-26 |
| K760443 | CARDIAC ELECTRODE | Meadox Medicals, Div. Boston Scientific Corp. | DTB | Class III | 1976-08-26 |
| K760151 | APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) | Edwards Laboratories | DTK | Class II | 1976-08-26 |
| K760403 | TEMPORARY ATRIAL ELECTRODE KIT | Usci, Div. C.R. Bard, Inc. | DRE | Class II | 1976-08-23 |
| K760234 | OXIMETER, IN VIVO CATHETER | Oximetrix, Inc. | DQE | Class II | 1976-08-23 |
| K760280 | ELECTRODE SERIES 1401 | Andover Medical, Inc. | DRX | Class II | 1976-08-23 |
| K760402 | SYRINGE SET, 3-WAY THERMODILUTIN | Omp Laboratories, Inc. | DQO | Class II | 1976-08-23 |
| K760358 | ELECTRODE SERIES 1600 | Andover Medical, Inc. | DRX | Class II | 1976-08-23 |
| K760265 | ELCTROCARDIOGRAPH, EK-6 | Burdick Corp. | DPS | Class II | 1976-08-23 |
| K760351 | CATHETER, ARGYLE THORACIC | Sherwood Medical Industries | DWS | Class I | 1976-08-23 |
| K760064 | CATHETER, THERMAL DILUTION, ANIMAL & PED | Instrumentation Laboratory CO | KRB | Class II | 1976-07-21 |
| K760066 | TRAY, ICED INJECTABLE (26420) | Instrumentation Laboratory CO | DXL | Class II | 1976-07-21 |
| K760067 | CATHETER, THERMAL DILUTION, OPEN CHEST | Instrumentation Laboratory CO | KRB | Class II | 1976-07-21 |
| K760065 | CATHETER, THERMAL DILUTION, PEDIATRIC | Instrumentation Laboratory CO | KRB | Class II | 1976-07-21 |
| K760092 | GRAFT, COOLEY WOVEN VASCULAR, STERILE | Meadox Medicals, Div. Boston Scientific Corp. | DSY | Class II | 1976-07-20 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.