meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1980-04-02

Clearances · page 184 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K800614 MEDTEK #411 PORTABLE B-P INSTR. Med-Tek Corp. DXN Class II 1980-04-02
K800337 DVT PREVENTION SYS. MBE 22 PRESSURE U. Med-Bio Engineering, Inc. JOW Class II 1980-03-25
K792602 SUSI II PACEMAKER SURVEILLANCE MONITOR Ela Medical, Inc. DTC Class II 1980-03-25
K800573 IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC Telectronics, Inc. DXY Class III 1980-03-25
K800462 PERCUTANEOUS INTRODUCER SET Medical Components, Inc. DRE Class II 1980-03-19
K800377 CARDIOPLEGIA DELIVERY SYSTEM 3M Health Care, Sarns DTR Class II 1980-03-19
K800492 VSM-1 PHYSIOLOGICAL MONITOR Physio-Control Corp. DPS Class II 1980-03-18
K800326 ARCOLITH 3021-CARDIAC PULSE GENERATOR Arco Medical Products Co. DXY Class III 1980-03-17
K792441 CARPENTIER-EDWARDS FLEX. ANNULOPLASTY Edwards Laboratories KRH Class II 1980-03-17
K800401 INFRASONDE D4000 ELECTRONIC B-P MONITOR Sphygmetrics, Inc. DXN Class II 1980-03-12
K800461 CENTRAL VENOUS PRESSURE CATHETER Medical Components, Inc. DQO Class II 1980-03-12
K800286 CRITERION II PACING SYSTEM MONITORS Dart Medical Equipment DTC Class II 1980-03-12
K800225 MICRONTA BP-1 ELECTRONIC B/P TESTER Tandy Corp. DXN Class II 1980-03-10
K800005 ECG MONITOR OSCILLOSCOPE MODEL OEC-3100 Nihon Kohden America, Inc. DPS Class II 1980-03-05
K800004 ECG MONITOR OSCILLOSCOPE MODEL OEC-3200 Nihon Kohden America, Inc. DPS Class II 1980-03-05
K800360 OUTPUT DIGITAL DISPLAY MODULE, MOD. 611 Output, Inc. DSK Class II 1980-02-29
K800066 NIASTAT Invivo Research Labs, Inc. DXN Class II 1980-02-29
K800222 MODEL 412 ELECTROFLUIDIC MANOMETER Med-Tek Corp. DXW Class II 1980-02-29
K800214 CIRCAMED I Circadian, Inc. DSH Class II 1980-02-29
K800149 USCI SAUVAGE EXS VASCULAR PROSTHESIS C.R. Bard, Inc. DSY Class II 1980-02-28
K800201 ESOPHAGEAL PILL-ELECTRODE Arzbaecher & Co. DRX Class II 1980-02-26
K792436 VXTRA BACK PACK EKG ELECTRODE CAT. NO. Vxtra Corp. DRX Class II 1980-02-22
K800236 ABCO MERCURIAL SPHYGMOMANOMETER Abco Dealers, Inc. DXQ Class II 1980-02-22
K800178 EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc. DWE Class II 1980-02-21
K792373 IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- Ipco Corp. DXK Class II 1980-02-13
K800179 INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR Sphygmetrics, Inc. DXW Class II 1980-02-11
K792646 AMP DIRECT VASCULAR MONITORING SYSTEM American Medical Products, Inc. KRH Class II 1980-02-11
K800194 OVALITH P-BP BIPOLAR CARDIAC PACEMAKER Coratomic, Inc. DXY Class III 1980-02-11
K792454 PNEUPAC RESUSCITATOR INSTANT ACTION SET Pneupac , Ltd. DRM Class II 1980-02-05
K792526 PULSE GENERATOR, MODEL NO. LIT 222 Bentley Laboratories, Inc. DXY Class III 1980-02-05
K792452 PNEUPAC RESUSCITATOR INSTANT ACTION SET Pneupac , Ltd. DRM Class II 1980-02-05
K792451 PNEUPAC RESUSCITATOR INSTANT ACTION SET Pneupac , Ltd. DRM Class II 1980-02-05
K792458 PNEUPAC TEST SET, PT.#500-A250 Pneupac , Ltd. DRM Class II 1980-02-05
K800151 EMIT TOBRAMYCIN CONTROL Syva Co. DPW Class II 1980-02-05
K792565 SORIN PULSE GENERATOR MODEL # LIT 214 H Bentley Laboratories, Inc. DXY Class III 1980-02-05
K800122 HANCOCK AORTIC PUNCH Hancock Laboratories, Inc. DWS Class I 1980-02-01
K800025 DINAMAP RESEARCH MONITOR 1245 Applied Medical Research DXN Class II 1980-02-01
K800135 CARDIOPLEGIA ADMINISTRATION SYSTEM CAS Bentley Laboratories, Inc. KRJ Class II 1980-02-01
K800171 DIAGNOSTIC INTRAVASCULAR CATHETER Flomed, Inc. DQO Class II 1980-02-01
K792536 CYNERGY MODEL 182 Cynergy DTE Class II 1980-01-31
K800026 MICROTHIN-DI Cardiac Pacemakers, Inc. DXY Class III 1980-01-31
K791975 PACING SYSTEM ANALYZER PSA SCE-22 Ela Medical, Inc. DTC Class II 1980-01-31
K800027 MICROTHIN-PI Cardiac Pacemakers, Inc. DXY Class III 1980-01-31
K800088 PACEMAKER ELECTRODE INSERTER AIDE Telectronics, Inc. DTE Class II 1980-01-29
K792466 NIC-200 VENTRICULAR FUNCTION ANALYZER Nicolet Biomedical Instruments DQC Class I 1980-01-24
K792430 CARDIASSIST EXTERNAL COUNTERPULSATION Cardiassist Corp. DRN Class II 1980-01-23
K792540 SONACOLOR 6000 Carolina Medical Electronics DXK Class II 1980-01-17
K800030 IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. Telectronics, Inc. DXY Class III 1980-01-11
K792135 DYE CURVE EVALUATOR Sci-Pro, Inc. DQK Class II 1980-01-11
K792354 THE CIRCULATOR BOOT Circulator Boot Corp. DRN Class II 1980-01-09
K792678 CARDIAC OUTPUT COMPUTER, M-MLC-4100 Nihon Kohden America, Inc. DXG Class II 1980-01-09
K792653 SENTRY Automated Screening Devices DXN Class II 1980-01-04
K792677 DATABASE MANAGEMENT & REPORTING SYSTEM Honeywell, Inc. DQK Class II 1980-01-04
K792604 LIFELINE TLE ENDOCARDIAL PACING LEAD, Intermedics, Inc. DTB Class III 1979-12-31
K792079 MODEL 447 ELECTROCARDIOCORDER Del Mar Avionics DSH Class II 1979-12-27
K792074 MODEL 674 PACER ANALYZER Del Mar Avionics DTC Class II 1979-12-27
K792525 IREX CARDIOPLAN Irex Corp. DQK Class II 1979-12-27
K792078 MODEL 449 ELECTROCARDIOCORDER Del Mar Avionics DSH Class II 1979-12-27
K792076 MODEL 448 PACERCORDER Del Mar Avionics DSH Class II 1979-12-27
K792519 IMPLANTABLE PROGRAMMABLE UNIPOLAR Telectronics, Inc. DXY Class III 1979-12-20
K791915 WHITE SEALING CAP Quinton, Inc. DQO Class II 1979-12-19
K792580 PACEMAKER PROGRAMMER Cardiac Pacemakers, Inc. KRG Class III 1979-12-19
K792576 CASTROVIEJO VASCULAR SCISSORS Edward Weck, Inc. DWS Class I 1979-12-19
K792226 CARDIVAN BLOOD PRESSURE MONITOR Paramed Technology, Inc. DRT Class II 1979-12-19
K792450 ARTERIAL BLOOD FILTER, MODEL AF-10 Bentley Laboratories, Inc. DTM Class II 1979-12-19
K792321 IMPLANTABLE END. MUSH. TIP LEADS030-224 Telectronics, Inc. DTB Class III 1979-12-13
K791890 CONTINUOUS FLUSH DEVICE, CAT. #14-370 Norton Performance Plastics Corp. KRA Class II 1979-12-13
K791793 USCI PRESSURE GAUGE C.R. Bard, Inc. DXT Class II 1979-12-11
K791782 USCI BALLOON DILATATION INFLATION DEV. C.R. Bard, Inc. DXT Class II 1979-12-11
K792034 INTEGRAL DISPOSABLE HOLDER CARPENTIER Edwards Laboratories DTJ Class I 1979-12-07
K792020 AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER Life Medical Services, Inc. DRS Class II 1979-12-07
K791792 SCI MED PERICARDIAL SUBSTITUTE Scimed Life Systems, Inc. DXZ Class II 1979-12-07
K792359 MEDTRONIC MODEL 9407 TELETRACE TRANSMITT Medtronic Vascular DXH Class II 1979-12-05
K792348 STANICOR, OMNI-STAN,MOD 333B,334A GAMMA Cordis Corp. DTX Class II 1979-12-05
K792141 CONTINUOUS FLUSH DEVICE Pharmaseal Div., Baxter Healthcare Corp. KRA Class II 1979-12-05
K792113 CONPHAR MANOMETER CONNECTORS Conphar, Inc. DTL Class II 1979-12-05
K792379 CARDIAC PACING ELECTRODE Medi-Dyne Instruments, Inc. DTB Class III 1979-12-05
K792387 IMPLANTABLE ENDOCARDIAL TINED ELECTRODE Telectronics, Inc. DTB Class III 1979-12-05
K792355 ANEROID SPHYMOMANOMETER Abco Dealers, Inc. DXQ Class II 1979-12-05
K792080 MODEL 656 ARRHYTHMIA ANALYZER Del Mar Avionics DXG Class II 1979-12-04
K792015 P-2 ULTRASONIC ARTERIOGRAPH D. E. Hokanson, Inc. DPT Class II 1979-12-04
K792134 BONCHEK-SHILEY VEIN DISTENTION SYSTEM Shiley, Inc. DWP Class II 1979-12-04
K792112 CONPHAR STETHSCOPE Conphar, Inc. DQD Class II 1979-12-04
K792077 MODEL 1981 PRESSUROMETER DATA ANALYSIS Del Mar Avionics DSK Class II 1979-12-04
K792075 MODEL 1978 PRESSUROMETER III AMBULATORY Del Mar Avionics DXN Class II 1979-12-04
K792108 CONPHAR BLOOD PRESSURE CUFFS Conphar, Inc. DXQ Class II 1979-12-04
K792223 PACESETTER MODEL 350 Cynergy DTE Class II 1979-11-30
K791920 CARDIAC PACEMAKER P4000 SER. & P1000 Vitatron Medical BV DXY Class III 1979-11-29
K792216 ARCOLITH 2100-CARDIAC PULSE GENERATOR Arco Medical Products Co. DXY Class III 1979-11-29
K792299 ARCOLITH 3020-CARDIAC PULSE GENERATOR Arco Medical Products Co. DXY Class III 1979-11-29
K791756 VDC Life Sciences Manufacturing, Inc. DXG Class II 1979-11-27
K792232 UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR American Pacemaker Corp. DXY Class III 1979-11-27
K792122 CHRONAEROBIC (CA-1) Stanford Scientific, Inc. DRT Class II 1979-11-27
K791955 UNIFOCAL 1 UNIPOLAR DEMAND R WAVE American Pacemaker Corp. DXY Class III 1979-11-27
K792199 UNIFOCAL 2-UNIPOLAR & BIPOLAR American Pacemaker Corp. DXY Class III 1979-11-27
K791419 OMNICOR PROGRAMMER MODEL 222C Cordis Corp. KRG Class III 1979-11-27
K792312 HEART RATE MONITOR MD-1 Medical Devices, Inc. DRT Class II 1979-11-21
K792246 MEDTRONIC MODEL 9408 TELETRACE TRANSMIT Medtronic Vascular DXH Class II 1979-11-21
K792283 ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON Arzbaecher & Co. DRR Class II 1979-11-21
K792229 ELECTROCARDIOGRAPH, MODEL ECG-5151 Nihon Kohden America, Inc. DPS Class II 1979-11-21

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