meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1980-06-30

Clearances · page 183 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K801393 AIR ASPIRATOR NEEDLE Texas Medical Products, Inc. DWS Class I 1980-06-30
K800837 PROGRAMMABLE BIPOLAR CARDIAC GENERATOR Arco Medical Products Co. DXY Class III 1980-06-30
K801402 QUICKIE PRIME CARDIOP. BYPASS PERF. INTR Texas Medical Products, Inc. DTL Class II 1980-06-30
K801401 CARDIOPULMONARY BYPASS TUBING Texas Medical Products, Inc. DWF Class II 1980-06-30
K801394 CARDIOPULMONARY BYPASS PUMP TUBING Texas Medical Products, Inc. DWE Class II 1980-06-30
K800795 PERMANENT & TEMP. PACEMAKER ELECTRODE Daig Corp. DTB Class III 1980-06-30
K801400 DISPOSABLE SUCKER SYSTEM Texas Medical Products, Inc. DTS Class II 1980-06-30
K801404 DISPOSABLE PARALLEL Y CONNECTORS Texas Medical Products, Inc. DTL Class II 1980-06-30
K801397 VENA CAVA CANNULAE Texas Medical Products, Inc. DWF Class II 1980-06-30
K801224 CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM Cambridge Instruments, Inc. DXK Class II 1980-06-26
K800069 MEDTRONIC MODELS 5966/5967, ETC. Medtronic Vascular DXY Class III 1980-06-26
K801136 D300 DOME Gics Pharmaceuticals DRS Class II 1980-06-20
K801022 ULTRA-CHEK PACEMAKER MONITOR Powers Medical Systmes KRE Class II 1980-06-17
K801188 CONPHAR DESK TOP MERCURY SPHYGMOMAN Conphar, Inc. DXQ Class II 1980-06-09
K801187 CONPHAR CHECKMATE SPHYGMOMANOMETER Conphar, Inc. DXN Class II 1980-06-09
K801186 CONPHAR DELUXE ANEROID SPHYGMOMANOMETER Conphar, Inc. DXQ Class II 1980-06-09
K801147 PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 Bentley Laboratories, Inc. DTM Class II 1980-06-04
K801183 CONPHAR DUAL HEAD STETHOSCOPE Conphar, Inc. LDE Class I 1980-06-04
K801182 CONPHAR WALL MODEL MERCURY SPHYGMOMAN. Conphar, Inc. DXQ Class II 1980-06-04
K801185 CONPHAR BOWLS STETHOSCOPE Conphar, Inc. LDE Class I 1980-06-04
K800838 ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. Arco Medical Products Co. DXY Class III 1980-06-04
K801189 CONPHAR SUPERTONE STETHOSCOPE Conphar, Inc. DQD Class II 1980-06-04
K801200 SAMPLING MANIFOLD H530 C.R. Bard, Inc. DTL Class II 1980-06-04
K792300 LIFELINE TLE (TRAEBECULAR LODGING ELEC Intermedics, Inc. DTB Class III 1980-06-04
K800904 TONOTEST BLOOD PRESSURE MONITOR Retlif, Inc. DXN Class II 1980-06-04
K801240 BUILT-IN TEMPERATURE MONITORING Bentley Laboratories, Inc. DTZ Class II 1980-06-04
K801184 CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE Conphar, Inc. LDE Class I 1980-06-04
K792301 LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL Intermedics, Inc. DTB Class III 1980-06-04
K801215 ABCO PEDIATRIC STETHOSCOPE Abco Dealers, Inc. LDE Class I 1980-06-04
K800354 LEAD, TINED PACING, IMPLANTABLE Daig Corp. DTB Class III 1980-05-30
K801099 UNICUF, BLOOD PRESSURE CUFF Frontier Products DXQ Class II 1980-05-30
K800351 PACEMAKER, ELECTRODE, PERM. & TEMP. Daig Corp. DTB Class III 1980-05-28
K800349 ENDOCARD. PACING LEAD LONG LENGTH PL200 Diag Corp. DTB Class III 1980-05-28
K801001 AMBULATORY MONITOR AM-1 Burdick Corp. DSH Class II 1980-05-28
K800891 RESTERILIZATION OF IMPLANTABLE ELECTRODE Telectronics, Inc. DTB Class III 1980-05-28
K800353 ADAPTER KIT Daig Corp. DTD Class II 1980-05-28
K800350 ENDOCARD. PACING LEAD STD. LENGTH PL202 Daig Corp. DTB Class III 1980-05-28
K800348 UNIPOLAR LEAD CONFIGURATION CONDUCTOR Daig Corp. DTB Class III 1980-05-28
K800347 PERM. INPLANT ENDOCARD. PAC. LEAD Daig Corp. DTB Class III 1980-05-28
K800355 LEAD, SUTURELESS MYOCARDIAL Daig Corp. DTB Class III 1980-05-28
K800356 PERMANENT LEAD INTRADUCER Daig Corp. DYB Class II 1980-05-28
K800782 PACE-PULSE/COMPUTRAC Bib, Inc. KRE Class II 1980-05-28
K800352 PACEMAKER, ELECTRODE Daig Corp. DTB Class III 1980-05-28
K801173 ANGIO-FLO MONITORING KIT Hospital Products Co. KRA Class II 1980-05-28
K801000 LARGE SCREEN CRT DISPLAY #1311B Hewlett-Packard Co. DXJ Class II 1980-05-28
K801156 USCI INTRALUMINAL GRAFT W/DACRON TIE C.R. Bard, Inc. DSY Class II 1980-05-23
K800937 R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 R2 Corp. LDD Class II 1980-05-23
K800932 ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 R2 Corp. DSA Class II 1980-05-23
K800930 R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. R2 Corp. DRX Class II 1980-05-23
K800936 R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 R2 Corp. LDD Class II 1980-05-23
K801165 HYPERSTETHOSCOPE, MODEL Z 00 Demonbinder Electronics DQD Class II 1980-05-23
K800935 R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) R2 Corp. DRX Class II 1980-05-23
K801041 3M R.F. CURRENT SUPPRESSOR 3M Company DSA Class II 1980-05-23
K800931 R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 R2 Corp. DSA Class II 1980-05-23
K800285 MODEL 5985 PACEMAKER PULSE GENERATOR Medtronic Vascular DXY Class III 1980-05-20
K801110 PRESSURE MONITOR, MODEL 1131B American Optical Corp. DSK Class II 1980-05-20
K801097 SARNS 7000 MONITOR MODULE 3M Health Care, Sarns DTQ Class II 1980-05-20
K790755 SMEC BALLOON CANNULA Smec, Inc. DSP Class II 1980-05-14
K801064 DISPOSABLE PATIENT CABLE MODEL 5807 Daig Corp. DSA Class II 1980-05-14
K801048 ACCUDYNAMIC Sorensen Research DRS Class II 1980-05-14
K800880 PLASTIC TUBING ADAPTERS 5-IN-1- Harvard Laboratories DTL Class II 1980-05-14
K800387 PULSE GENERATORS MODELS 657 & 677 Siemens Elema AB DXY Class III 1980-05-02
K800778 DIGITAL ELECTRONIC B.P. MONITOR 2155 Sears, Roebuck & Co. DXN Class II 1980-04-29
K800823 QUICK FILL Medrad, Inc. DXT Class II 1980-04-29
K800622 EXTENSION LINE Norton Performance Plastics Corp. DQO Class II 1980-04-29
K800895 MODEL 253-11 CYBERLITH PULSE GENERATOR Intermedics, Inc. DXY Class III 1980-04-24
K800766 ECHO-COMP Digisonics, Inc. DQK Class II 1980-04-24
K800619 THERMODILUTION CATHETER INTRO. KIT Norton Performance Plastics Corp. DYB Class II 1980-04-24
K800767 MOD. MCI 17 MANUAL CUFF INFLATOR Medasonics, Inc. DXQ Class II 1980-04-24
K800851 SERIES 602 CKGTM RECORDER Cardio Kinetics, Inc. DSF Class I 1980-04-24
K800618 SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET Norton Performance Plastics Corp. DQO Class II 1980-04-24
K800812 MEDI-THERM Gaymar Industries, Inc. DWJ Class II 1980-04-24
K800620 VENOUS M/A INTERNAL JUGULAR KIT Norton Performance Plastics Corp. DYB Class II 1980-04-24
K800621 PERCUTANEOUS CATHETER INTRODUCER ADAPTER Norton Performance Plastics Corp. DYB Class II 1980-04-24
K800836 KMA FLOW DIRECTED THERMODILUTION CATHETE Kma, Inc. KRB Class II 1980-04-24
K800147 FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. Usifroid KRH Class II 1980-04-24
K800376 EPR-200 PROGRAMMER MODEL 010 Biotronik Sales, Inc. KRG Class III 1980-04-21
K800375 NOMOS-01 PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1980-04-16
K800705 MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO Graphic Controls Corp. DRS Class II 1980-04-16
K800298 USCI BIPOLAR BALLON PACING ELECTRODE C.R. Bard, Inc. LDF Class II 1980-04-16
K800644 CYBERLITH IMPLANTABLE PULSE GEN. #253-02 Intermedics, Inc. DXY Class III 1980-04-16
K800706 MEDI-TRACE DISPOSABLE DOMES/MONITORING Graphic Controls Corp. DRS Class II 1980-04-16
K800655 MODEL 100 SPECTRAVIEW Edwards Laboratories DQC Class I 1980-04-16
K800741 CENTRAL VEIN CATHETERIZATION KIT Medical Components, Inc. DQO Class II 1980-04-16
K800488 SURGERY DISPLAY SYSTEM Kent Barker & Assoc. DRQ Class II 1980-04-16
K800717 TOPICAL COOLING DEV. TCD. #27-999 Cobe Laboratories, Inc. DTR Class II 1980-04-16
K800243 D668 & D664 CENTRAL MONITORING SYSTEMS Medtel Pty. , Ltd. DRT Class II 1980-04-10
K800663 MARK III Applied Science Laboratories DXN Class II 1980-04-08
K800659 SCHILLER MSG-1 Renesco International, Inc. DPS Class II 1980-04-08
K800662 MARK II Applied Science Laboratories DXN Class II 1980-04-08
K800500 PULSEOMETER Kirklands Sporting Goods Co. DRT Class II 1980-04-08
K800645 CYBERLITH IMPLANTABLE PULSE GEN. #253-04 Intermedics, Inc. DXY Class III 1980-04-08
K800661 MODEL S/D-600 AUTO INFLATE CONTROL MODUL Applied Science Laboratories DXN Class II 1980-04-08
K800566 CAMBRIDGE VS-550 ELECTROCARDIOGRAPH Cambridge Instruments, Inc. DPS Class II 1980-04-08
K800613 ANGIOPLASTY INJECTOR Medrad, Inc. DXT Class II 1980-04-08
K800703 MODIFIED CATHETER PACKAGE Hancock Laboratories, Inc. DQO Class II 1980-04-08
K800092 COMBISON COMPUTER Kt Medical, Inc. DQK Class II 1980-04-08
K800555 PARTNER SEVEN DISP. BUBBLE OXYGENATOR Cardiovascular Research, Inc. DTZ Class II 1980-04-04
K800593 SIRECUST 311S Siemens Corp. DPS Class II 1980-04-02
K800580 PERCUTANEOUS CATHETER INTRODUCER Alva Medical, Inc. DYB Class II 1980-04-02

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