meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
1978-11-30

Clearances · page 188 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K781911 ECG ANALYZER, HIGH SPEED Cardio-Dynamics Laboratories, Inc. DSI Class II 1978-11-30
K781940 EKG ELECTRODES, DISPOSABLE Hayes Products, Inc. DRX Class II 1978-11-29
K781692 CALIBRATOR, DYNAMIC Waters Assoc., Inc. DXM Class II 1978-11-29
K781954 CATHETER INTRODUCERS, ARTERISE C.R. Bard, Inc. DYB Class II 1978-11-29
K781932 BLOOD PRESSURE RECORDER Cardiodyne, Inc. DXN Class II 1978-11-29
K780479 DELTA-FLOW Tri-Delta Intl. KRA Class II 1978-11-22
K781845 CAMSCAN SYSTEM American Optical Corp. DSI Class II 1978-11-20
K781906 BLOOD PRESSURE DEVICE, 400 SERIES Med-Tek Corp. DXN Class II 1978-11-16
K781671 BLOOD PRESSURE CUFF COVER David Cott Co. DXQ Class II 1978-11-16
K781861 FILTER, EXTRACORPOREAL BLOOD HOLDER Surgikos, Inc. KRI Class I 1978-11-15
K781842 OXYGENATOR, BLOOD BOS-10 Bentley Laboratories, Inc. DTZ Class II 1978-11-08
K781561 ANGIOGRAPHIC GUIDE WIRE Wilson Medical Instruments Co. DQX Class II 1978-11-07
K781843 RECORDER, HOLTER ELECTROCARDIOGRAM Hovik Corp. DSH Class II 1978-11-03
K781430 PREGELLED DISPOSABLE E.K.G. ELECTRODE Vermont Medical, Inc. DRX Class II 1978-10-31
K781393 VARIABLE STIFFNESS WIRE GUIDE Cook, Inc. DQX Class II 1978-10-30
K781352 STRAIN GAUGE PLETHYSMOGRAPH Medimatic DSB Class II 1978-10-27
K781776 PACING LEADS MODEL UL-811 AND UL-813 Pacesetter Systems DTB Class III 1978-10-27
K781707 FILTER, ARTERIAL BLOOD W/TUBING BYPASS Surgikos, Inc. DTM Class II 1978-10-26
K781514 ECG ELECTRODE, 2021, 2022, 2032, 2033 Cardio-Dynamics Laboratories, Inc. DRX Class II 1978-10-17
K781556 PRESSURE INFUSION CUFF Abbott Laboratories DXN Class II 1978-10-17
K781166 MONITOR, HEART RATE Cybernetic Medical, Inc. DRT Class II 1978-10-15
K781336 SURGITEK DISPOSABLE FLO-RESTER Medical Engineering Corp. DWS Class I 1978-10-10
K781210 HEAT EXCHANGER, FHX-14 Delta Medical Industries DTR Class II 1978-10-10
K781558 PRESSURE MONITORING INJECTION LINES Cobe Laboratories, Inc. DQO Class II 1978-10-10
K781115 PRINTER, DIGITAL Output, Inc. DSF Class I 1978-10-06
K781680 MONITORING, PRESSURE KIT Pharmaseal Div., Baxter Healthcare Corp. DRS Class II 1978-10-06
K781518 PREGELLED DISPOSABLE ELECTRODE Vente Medical Products, Inc. DRX Class II 1978-10-06
K781579 MODIFIED STERILE DISPOSABLE STOPCOCKS Cobe Laboratories, Inc. DTL Class II 1978-10-05
K780776 ARCOBIOLITH PACEMAKER MODEL Arco Medical Products Co. DXY Class III 1978-10-03
K781252 GENERATOR, PULSE, MODEL 5997 Medtronic Vascular DXY Class III 1978-10-03
K781208 GENERATORS, PULSE, MODELS 5988/5989 Medtronic Vascular DXY Class III 1978-10-03
K780940 GENERATOR, PULSE, MODEL 160B Telectronics, Inc. DXY Class III 1978-09-27
K781577 DISPOSABLE CARDIOTOMY; H-700F, H-700 C.R. Bard, Inc. DTN Class II 1978-09-27
K781383 INTERFACE CARDIOTOMY BLOOD FILTER Medical, Inc. JOD Class II 1978-09-27
K772226 PACEMAKER, MODEL 225 & 227 Intermedics, Inc. DXY Class III 1978-09-27
K781407 ERM-101 Cynergy DRT Class II 1978-09-27
K781424 GENERATORS: UDL-201B, BDL-201B, MDL-201B Pacesetter Systems DXY Class III 1978-09-27
K781163 ELECTRODE, DEIP. Datascope Corp. DRX Class II 1978-09-26
K781357 T.E.D. SEQUENTIAL COMPRESSION SLEEVES Kendall Research Center JOW Class II 1978-09-20
K781387 INSTA-PULSE HEART RATE MONITOR Bio Sig Instruments, Inc. DRT Class II 1978-09-20
K781292 CARDIOPNEUMOGRAPH Street Electronics Corp. DRT Class II 1978-09-20
K781358 SEQUENTIAL CUFF INFLATION DEVICE Medasonics, Inc. JOW Class II 1978-09-20
K781256 CATHODE RAY TUBE MED. DISPLAY Rae Medical Corp. DXJ Class II 1978-09-20
K781255 DIGITAL PANEL METER Rae Medical Corp. DRT Class II 1978-09-20
K781535 AC ADAPTER:MODELS 9525,9526,9527 Edwards Laboratories DXG Class II 1978-09-15
K780078 OXYGENATOR, BUBBLE TYPE Bentley Laboratories, Inc. DTZ Class II 1978-09-14
K781413 MASK, PXYGEN Vitalab Products Corp. DPT Class II 1978-09-07
K781053 DINAMAP MODEL 846 Applied Medical Research DSK Class II 1978-09-07
K781090 GENERATOR, CARDIAC PULSE, 250B Telectronics, Inc. DXY Class III 1978-09-07
K781426 CARDIAL PULSE GENERATORS Telectronics, Inc. DXY Class III 1978-09-07
K781178 PULSE GENERATOR MODEL 208 Elema-Schonander, Inc. DXY Class III 1978-09-07
K781064 DINAMAP MODEL 848 Applied Medical Research DSK Class II 1978-09-07
K781349 PACER-TRACER PULSE WIDTH Instromedix, Inc. DTC Class II 1978-08-31
K780953 MODEL 1861 BLOOD PUMP Medtronic Vascular KFM Class II 1978-08-31
K780937 MODEL 20 DIGITAL PULSE RATE MONITOR Sentronix, Inc. DRT Class II 1978-08-31
K780952 MODEL 1812 CONTROL CONSOLE, ACCESSORIEX Medtronic Vascular DWA Class II 1978-08-31
K781152 ELECTROCARDIOGRAPHIC ECG RECORDER Cardio-Dynamics Laboratories, Inc. DSM Class I 1978-08-31
K781168 GENERATOR, PULSE, PACEMAKER Vitatron Medical BV DXY Class III 1978-08-31
K780246 PACEMAKER, ELECTRODE, PERMANENT & TEMP. Daig Corp. DTB Class III 1978-08-31
K781144 ANALYZER, PACER SYSTEM, PSA-5 Edwards Pacemaker Systems DTC Class II 1978-08-23
K781221 DILUTION KIT, THERMAL, COLD PAC Instrumentation Laboratory CO DRC Class II 1978-08-23
K781134 CATHETER, THERMAL DILUTION FIBEROPTIC Oximetrix, Inc. DQE Class II 1978-08-17
K781334 DISPOSABLE SYRINGE FILL TUBE Mallinckrodt Group, Inc. DXT Class II 1978-08-17
K780809 GENERATOR, PULSE MODELS 5920/5921 Medtronic Vascular DXY Class III 1978-07-28
K780622 BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 Medtronic Vascular DTB Class III 1978-07-28
K780623 ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 Medtronic Vascular DTB Class III 1978-07-28
K780741 GENERATOR, PULSE, DEMAND, MODEL 5996 Medtronic Vascular DXY Class III 1978-07-28
K781223 OXYGENATOR, BLOOD, INFANT/PEDIATRIC Shiley, Inc. DTZ Class II 1978-07-27
K781042 PROLITH 23S PACEMAKER Edwards Pacemaker Systems DXY Class III 1978-07-27
K781179 WRENCH, GEXAGON, DRIVER Telectronics, Inc. DTF Class I 1978-07-27
K781054 LIFELINE AMBULATORY Imc DPS Class II 1978-07-27
K780561 VENTRICULAR INHIBITED PULSE GENERATOR Medtronic Vascular DXY Class III 1978-07-27
K780420 GENERATOR, PULSE, CARDIAC, IMPLANTABLE Telectronics, Inc. DXY Class III 1978-07-27
K780781 STILITH CARDIAC PACEMAKERS-M. 60 & 120 R.E. Brown Co., Inc. DXY Class III 1978-07-27
K781145 MONITOR KITS, BLOOD LEVEL 3M Health Care, Sarns DTW Class II 1978-07-27
K780621 LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED Medtronic Vascular DTB Class III 1978-07-26
K780986 DIGITAL BLOOD PRESSURE MONITOR Sears, Roebuck & Co. DXN Class II 1978-07-18
K780984 PVC QUICK PRIME LINES Norton Performance Plastics Corp. KRI Class I 1978-07-17
K780738 PENTAX ST-1A Hal-Hen Co., Inc. DQD Class II 1978-07-17
K780715 ANEROID TYPE BLOOD PRESSURE KIT Mars Metal Co., Ltd. DXQ Class II 1978-07-17
K780421 GENERATOR, PULSE, CARDIAC, IMPLANTABLE Telectronics, Inc. DXY Class III 1978-07-07
K780780 MICROPULSE 22S PACEMAKER Edwards Pacemaker Systems DXY Class III 1978-06-30
K780717 EXTERNAL TEST PULSE GENERATOR Vitatron Medical BV DTC Class II 1978-06-30
K780761 ELECTRO-PLETHYSMOGRAPH Biotecx Laboratories, Inc. JOM Class II 1978-06-30
K780453 STANICOR THETA MODEL 221 CARDIAC PACER Cordis Corp. DXY Class III 1978-06-30
K780438 SAFETY SPRING GUIDES, TEFLON COATED C.R. Bard, Inc. DQX Class II 1978-06-28
K780597 ECG PAPER, 3 CHANNEL Abco Dealers, Inc. DSF Class I 1978-06-28
K780445 LIQUID CRYSTAL DISPLAY DIGITAL WATCH Hughes Aircraft Co. DRT Class II 1978-06-19
K780942 BLOOD PUMP MODEL 7000 3M Health Care, Sarns DWB Class II 1978-06-19
K780468 CLINICAL GRAPHICS ANALYZER Numonics Corp. DQK Class II 1978-06-19
K780908 SELF-RETAINING ELECTRODE SER. #4000-100 Andover Medical, Inc. DRX Class II 1978-06-19
K780569 L-12, L-21, AND L-22 ELECTRODES Coratomic, Inc. DTB Class III 1978-06-14
K780653 EXTRACORPEAL CARDIOTOMY BLOOD FILTER Cobe Laboratories, Inc. JOD Class II 1978-06-14
K780782 M. 1336S CATHODE-RAY TUBE DISPLAY Hewlett-Packard Co. DXJ Class II 1978-06-14
K780754 NEONATAL MONITOR Applied Medical Research DXN Class II 1978-06-14
K780797 TRANSDUCER, PRESSURE, OPTION, H-P, P23ID Gould, Inc. DRS Class II 1978-06-13
K780798 GOULD-STATHAM SP1405 PRESSURE MONITOR Gould, Inc. DSK Class II 1978-06-13
K780598 TREND II ANEROID Abco Dealers, Inc. DXN Class II 1978-06-06
K780805 S/D 600 SPHYGMOMANOMETER AND PULSEMETER G & W Applied Science Laboratories DXN Class II 1978-06-06
K780356 OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 Output, Inc. DSK Class II 1978-05-31

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