meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
1978-05-26

Clearances · page 189 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K780762 EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE Shiley, Inc. DXE Class II 1978-05-26
K780768 MODEL 5621A INTERFACE Hewlett-Packard Co. DQK Class II 1978-05-26
K780432 ARRHYTHMIA PROGRAM MODULE Midwest Analog & Digital, Inc. DSI Class II 1978-05-26
K780446 SUTURELESS MYOCARDIAL PACING LEAD Medtronic Vascular DTB Class III 1978-05-19
K780702 CSS-60 DIGITAL HEART RATE METER Burdick Corp. DRT Class II 1978-05-19
K780297 CARDIAC MINISCOPE & MINIGRAPH Arco Medical Products Co. DRT Class II 1978-05-19
K780501 ELECTRODE TESTER Mg Medical Electronics KRC Class II 1978-05-19
K780307 CARDIAC MINIGRAPH Arco Medical Products Co. DPS Class II 1978-05-19
K780327 GENERATORS, ATRIAL INHIBITED PULSE Medtronic Vascular DXY Class III 1978-05-18
K780677 4600 RECORDER G & W Applied Science Laboratories DSF Class I 1978-05-17
K780777 BAGS, PLASTIC, STERILE FOR GENERATORS Telectronics, Inc. DXY Class III 1978-05-16
K780571 BLOOD PRESSURE MODULE C-V Monitors Corp. DRQ Class II 1978-05-09
K780529 MYOCATH KIT Sorensen Research DQO Class II 1978-05-09
K780572 DCG PREAMPLIFIER MODULE C-V Monitors Corp. DRR Class II 1978-05-09
K780358 ACCES. ANALOG OUTPUT ADAPTOR MODEL 910 Applied Medical Research DXN Class II 1978-04-28
K780640 DRY SILVER PROCESSOR MODEL 1226 Honeywell, Inc. DSF Class I 1978-04-28
K780530 AUTOMATED PHYSIOLOGIC PROFILER Bd Becton Dickinson Vacutainer Systems Preanalytic DQK Class II 1978-04-28
K780567 AORTIC PUMP ETHICON, Inc. DWS Class I 1978-04-28
K780625 UNISTAT OXIMETER American Optical Corp. DQA Class II 1978-04-28
K780425 BIOPHYSICAL MONITORING SYSTEM Gould, Inc. DXJ Class II 1978-04-28
K780416 PANTRIDGE MK III DEFIBRILLATOR/MONITOR Ipco Corp. LDD Class II 1978-04-21
K780566 HEALTH SEAT SYSTEM G & W Applied Science Laboratories DXN Class II 1978-04-21
K780175 RATE PROGRAMMER MODEL 520 Intermedics, Inc. KRG Class III 1978-04-21
K780532 PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc. DYB Class II 1978-04-21
K780302 BLOOD FLOWMETER SYSTEM Medtronic Vascular DPW Class II 1978-04-21
K780343 ARRHYTHMIA TREND ENHANCEMENT American Optical Corp. DSI Class II 1978-04-18
K780244 CATHETERS, ARTERIAL EMBOLECTOMY Extracorporeal Medical Specialities, Inc. DXE Class II 1978-04-13
K780517 CARDIOTOMY RESERVOIR Travenol Laboratories, S.A. DTN Class II 1978-04-13
K780477 PHYSIOLOGICAL PRESSURE TRANSDUCER Bell & Howell Instruments DRS Class II 1978-04-13
K780493 ELECATH PLASTIC JACKETED GUIDEWIRE Electro-Catheter Corp. DQX Class II 1978-04-10
K780437 PACEMAKER, MODEL 252, C-MOS Intermedics, Inc. DXY Class III 1978-04-05
K780485 PREBYPASS FILTER Delta Medical Industries KRJ Class II 1978-04-05
K780404 ECG MONITORING SYSTEM, Quinton, Inc. DRT Class II 1978-03-28
K780245 RECORDER, RE-100P HOT STYLUS STRIP CHART Waters Assoc., Inc. DSF Class I 1978-03-27
K780332 CATHODE RAY TUBE DISPLAY MODEL 1340A Hewlett-Packard Co. DXK Class II 1978-03-22
K780158 TELETRACE TELEPHONE EKG TRANSMITTER Medtronic Vascular DXH Class II 1978-03-21
K780238 PACEMAKER, PROLITH 23U. PULSE GENERATOR Edwards Pacemaker Systems DXY Class III 1978-03-15
K780280 BALLOON PUMP Datascope Corp. DSP Class II 1978-03-15
K780046 ULTRASPHYG BLOOD PRESSURE OPTION Cavitron Corp. DXN Class II 1978-03-15
K780338 MINYSTAG MN-1 Lkb Instruments, Inc. DSF Class I 1978-03-15
K772350 PATIENT ALERT MODEL 555 Intermedics, Inc. DXH Class II 1978-03-09
K780126 DILATOR, VESSEL & INTRODUCER, SHEATH Argon Medical Corp. DRE Class II 1978-03-02
K780271 COBE STOPCOCK Cobe Laboratories, Inc. DTL Class II 1978-03-02
K772117 HEAT EXCHANGER, DISP., OMNITHERM Scimed Life Systems, Inc. DTR Class II 1978-03-02
K780247 IMPCO DISPOSABLE AORTIC PUNCH Thoratec Laboratories Corp. DWS Class I 1978-02-27
K780116 AMPLIFIER, PC-700 Burdick Corp. DQC Class I 1978-02-24
K780023 BLACK BAG, ELECTRONIC Marshall Electronics, Inc. LDE Class I 1978-02-21
K780166 STRESS TEST SYSTEM Quinton, Inc. DPS Class II 1978-02-21
K772334 MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP Telectronics, Inc. DSK Class II 1978-02-21
K780138 EK-670 Burdick Corp. DPS Class II 1978-02-17
K772333 RECORDER, PAPER, ECG Telectronics, Inc. DSF Class I 1978-02-13
K780079 CANNULA, ARTERY, RENAL Dravon Medical, Inc. DQR Class II 1978-02-13
K780043 ESIS MODULE Datascope Corp. DRR Class II 1978-02-13
K780113 CARDIAC PULSE GENERATOR, MODEL 160B Telectronics, Inc. DXY Class III 1978-02-13
K772332 MONITOR, CARDIAC, BEDSIDE Telectronics, Inc. DRT Class II 1978-02-13
K772309 ENDOCARDIAL PACING ELECTRODE Coratomic, Inc. DTB Class III 1978-02-06
K780117 CARDIOMETER Med General DRT Class II 1978-02-03
K772186 ELECTROCARDIOGRAPH TRANSMITTER, 536 Intermedics, Inc. DXH Class II 1978-02-02
K772284 BUBBLE-TYPE OXYGENATOR Cobe Laboratories, Inc. DTZ Class II 1978-02-02
K780056 OXYGENATOR HOLDER C.R. Bard, Inc. DTL Class II 1978-02-01
K780128 BLOOD PRESSURE MONITOR, ARTERIAL Applied Medical Research DRS Class II 1978-01-31
K780127 DINAMAP MODEL 850 Applied Medical Research DRS Class II 1978-01-31
K772050 TDL-100 B Pacesetter Systems DXY Class III 1978-01-30
K772238 PULSE GENERATOR, UNIPOLAR, PROGRAMABLE Cardiac Pacemakers, Inc. DXY Class III 1978-01-30
K772051 MDL-201 Pacesetter Systems DXY Class III 1978-01-30
K780066 CARDIAC PACER, MODEL 208 Cordis Corp. DXY Class III 1978-01-30
K772241 PULSE GENERATOR, BIPOLAR, DEMAND Cardiac Pacemakers, Inc. DXY Class III 1978-01-30
K772197 PACEMAKER, PERM. & TEMP., ELECTRODE Daig Corp. DTB Class III 1978-01-30
K780091 MICROPULSE 22U Edwards Pacemaker Systems DXY Class III 1978-01-30
K772240 PULSE GENERATOR, UNIPOLAR, DEMAND Cardiac Pacemakers, Inc. DXY Class III 1978-01-30
K772239 PULSE GENERATOR, BIPOLAR, PROGRAMMABLE Cardiac Pacemakers, Inc. DXY Class III 1978-01-30
K772369 NEEDLES USED IN ANGIOGRAPHIC PROCED. Argon Medical Corp. DRC Class II 1978-01-24
K772173 STETHOSCOPE, ELECTRONIC Affiliated Mailorder Co. Sales, Inc. DQD Class II 1978-01-24
K771981 MINIMAP MODEL 810 Applied Medical Research DSK Class II 1978-01-24
K780061 PULSE GENERATORS, MODELS 5972/5973 Medtronic Vascular DXY Class III 1978-01-24
K772357 PULSE GENERATORS Medtronic Vascular DXY Class III 1978-01-17
K772360 ARRHYTHMIA MODULE General Electric Co. DSI Class II 1978-01-12
K772331 RESTERIL. OF IMPLANT. ELECT. & ADAPTER Telectronics, Inc. DTB Class III 1978-01-11
K772203 VENTRICULAR LEADS Medtronic Vascular DTB Class III 1978-01-11
K772234 CARDIAC OUTPUT MODULE-78231C Hewlett-Packard Co. DSK Class II 1978-01-05
K771770 XYREL-RA MODELS 5994/5995 Medtronic Vascular DXY Class III 1978-01-04
K771786 CARDIAC PULSE GENERATORS 5982/5983 Medtronic Vascular DXY Class III 1978-01-04
K771977 CARDIAC OUTPUT COMPUTER MODEL 701 Instrumentation Laboratory CO DSK Class II 1978-01-03
K772299 TRANSPARENT MANIFOLD Uni-Research DTL Class II 1977-12-21
K772202 PULSE GENERATOR, A-V SEQ. Medtronic Vascular DXY Class III 1977-12-20
K771043 SWAN GANZ Clincal Instruments Corp. DYG Class II 1977-12-20
K771823 CATHETER, CARDIOVASCULAR Usci, Div. C.R. Bard, Inc. DYG Class II 1977-12-20
K772237 OXYGENATOR, BUBBLE Shiley, Inc. DTZ Class II 1977-12-13
K772178 PACER MONITOR, PULSE WIDTH Survival Technology, Inc. DXH Class II 1977-12-08
K772104 PACING LEAD MODEL 6991A Medtronic Vascular DTB Class III 1977-11-28
K772006 ACUTE CARDIAC CARE SYSTEM Physio-Control Corp. DRT Class II 1977-11-28
K772009 CARDIAC PACEMAKER S6001 Vitatron Medical BV DXY Class III 1977-11-28
K772152 CENTRAL MONITORING SYSTEM Burdick Corp. DXG Class II 1977-11-28
K772175 CATHETER SYSTEM, COPE/EISENBERG Victory Engineering Corp. DQO Class II 1977-11-28
K772010 CARDIAC PACEMAKER C2001 Vitatron Medical BV DXY Class III 1977-11-28
K771924 HEARTBEATER Dunn Instruments, Inc. DXG Class II 1977-11-28
K772132 AMPLIFIER MODULE, 78211A ECG Hewlett-Packard Co. DRR Class II 1977-11-22
K772052 PHYSIOLOGICAL RECORDER MODEL 721A Datascope Corp. DSF Class I 1977-11-22
K772000 ECG TELEMETRY SYSTEM Mennen Greatbatch Electonics DRG Class II 1977-11-22
K772054 PHYSIOLOGICAL RECORDER MODEL 740 Datascope Corp. DSF Class I 1977-11-22

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