meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
1979-11-21

Clearances · page 185 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K792070 SARNS MEDIASTINAL AND PERICARDIAL TUBE 3M Health Care, Sarns DWF Class II 1979-11-21
K792190 MODEL CF-300 THREE CHANNEL FLOW METER Wilton Webster Laboratories DRQ Class II 1979-11-21
K792202 TROCAR CATHETER/THORACIC CATHETER Portex, Inc. DWF Class II 1979-11-20
K792194 VITA-STAT MODEL 900-S Vita-Stat Medical Services, Inc. DXN Class II 1979-11-20
K792193 VITA-STAT MODEL 900-D Vita-Stat Medical Services, Inc. DXN Class II 1979-11-20
K791894 3M BRAND TOTAL LEG COMPRESSION TLC SYS. 3M Company JOW Class II 1979-11-16
K791316 MEDTRONIC MODELS 5984/5985 Medtronic Vascular DXY Class III 1979-11-15
K792177 MILLAR MIKRO-TIP CATHETER TRANSDUCER Millar Instruments, Inc. DXO Class II 1979-11-15
K790406 DELTA D-750 THERMAFLOW Delta Medical Industries DTZ Class II 1979-11-13
K792168 LIFELINE - ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1979-11-13
K792117 AIR-SHIELDS HEART RATE MONITOR Narco Air-Shields DRT Class II 1979-11-13
K791632 COMPU-SCAN Hittman Medical Systems DSI Class II 1979-11-13
K792051 CKG CARDIOKYMOGRAPH Cardio Kinetics, Inc. DSB Class II 1979-11-13
K792131 TEMPORARY TRANSVENOUS PACMKER. ELECTRODE Stanco Medical, Inc. DYB Class II 1979-11-13
K792171 COMPLETE TRAY CENTRAL VENOUS PRESSURE Stanco Medical, Inc. DYB Class II 1979-11-13
K791927 HEART RATE COMPUTER STRIP CHART Stanford Assoc., Inc. JOM Class II 1979-11-13
K792040 BARD BIOMEDICAL PRINTED SILVER ELECTRODE C.R. Bard, Inc. DRX Class II 1979-11-13
K791947 SHILEY CARDIOPLEGIC SOLUTION DEL SETS Shiley, Inc. DWF Class II 1979-11-13
K792192 VITA-STAT MODEL 900A Vita-Stat Medical Services, Inc. DXN Class II 1979-11-13
K791963 USCI MULLINS TRANSSEPTAL CATHETER INTRO. C.R. Bard, Inc. DYB Class II 1979-11-13
K791873 USCI SAFE-T-CLOTH THERMODILUTION CAT. C.R. Bard, Inc. KRB Class II 1979-11-13
K792170 PERCUTANEOUS SHEATH (MULTI-CATH)SIDE Stanco Medical, Inc. DYB Class II 1979-11-13
K792081 SPECTRA CENTRAL PT MONITORING SYS American Optical Corp. DSI Class II 1979-11-13
K792130 TRANSVENOUS BALLOON CATH. INTRO. KIT Stanco Medical, Inc. DYB Class II 1979-11-13
K792172 PERCUTANEOUS SHEATH INTRO. KIT OR TRAY Stanco Medical, Inc. DYB Class II 1979-11-13
K792151 OXYGENATOR GAS LINE FILTER Cardio Systems, Inc. KRI Class I 1979-11-13
K792152 CARDIOPLEGIA SOLUTION ADMIN. SET Cardio Systems, Inc. DWF Class II 1979-11-13
K791768 CORDIS PERMANENT PERVENOUS CARDIAC LEADS Cordis Corp. DTB Class III 1979-11-05
K791892 TAPE-A-TRACE Instromedix, Inc. DXM Class II 1979-11-05
K792072 MODEL 685/686 DYNAMIC ELECTROCARDI0- Del Mar Avionics DPS Class II 1979-11-05
K792073 MODEL 1979 BLOOD PRESSUROMETER R CHARTER Del Mar Avionics DRS Class II 1979-11-05
K792039 WILLIAM HARVEY H-1500 BLOOD OXYGENATOR C.R. Bard, Inc. DTZ Class II 1979-10-30
K792105 CRITIKON DUAL CHANNEL RECORDER Critikon Company, LLC DSF Class I 1979-10-26
K791921 CARDIAC PACEMAKER C4000, C1000 SER. Vitatron Medical BV DXY Class III 1979-10-26
K791858 CARDIOPLEGIA ADMIN. SETS Travenol Laboratories, S.A. DWF Class II 1979-10-26
K792099 50MM WRITER MODEL CVM 9529 C-V Monitors Corp. DSF Class I 1979-10-26
K792088 AORTIC OCCLUDER #000390 Edward Weck, Inc. DWS Class I 1979-10-26
K792052 IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD Telectronics, Inc. DXY Class III 1979-10-22
K791783 OMNI-STANICOR (THETA) MOD 237A Cordis Corp. DXY Class III 1979-10-22
K790792 PULSE GENERATOR MODEL 637 Elema-Schonander, Inc. DXY Class III 1979-10-12
K791972 ARGYLE PEDIATRIC VENA CAVAL CATHETER Sherwood Medical Co. DWF Class II 1979-10-11
K791964 MODEL 15055A MAINFRAME Hewlett-Packard Co. DRR Class II 1979-10-11
K791914 3-WAY STOPCOCK W/MALE LOCKING LUER ADA. Abbott Laboratories DTL Class II 1979-10-11
K791797 MTS CATHETER ADAPTER FOR GUIDANCE ENTRY Medical Testing System, Inc. DTL Class II 1979-10-11
K791810 VASCULAR GRAFT PROST. OF EXPANDED PTFE Impra, Inc. DYF Class II 1979-10-09
K791862 HEART RATE COMPUTER Stanford Assoc., Inc. DRT Class II 1979-10-04
K791875 PARKE-DAVIS TOTAL HIP PROSTHESIS Warner-Lambert Co. DXQ Class II 1979-10-04
K791832 VEIN GRAFT CANNULA D/P, Inc. DWF Class II 1979-10-04
K791418 VASCULIZER Diagnostics Intl. DPW Class II 1979-10-04
K791636 ACCUNAMIC Sorensen Research DRS Class II 1979-10-04
K791844 CRITIFLO & CRITIFLO DOME Gould, Inc. KRA Class II 1979-10-02
K791748 ULTIPOR BLOOD FILTER EXTRA-CORPOREAL Pall Biomedical Products Co. DTM Class II 1979-10-02
K791778 MEDTRONIC MODEL 9410 TELETRACE RECEIVER Medtronic Vascular DXH Class II 1979-10-02
K791776 ARRHYTHMIA II EDITOR Spacelabs, Inc. DQK Class II 1979-10-02
K791846 DISPOSSABLE SUCTION TUBE, 6 FRENCH Dlp, Inc. DTS Class II 1979-10-02
K791753 IPAG MICRONOVA INTERFACE #781111 Robinton Corp. DXG Class II 1979-10-02
K791829 SHILEY QUICK DISCONNECT ASSEMBLY Shiley, Inc. KRI Class I 1979-10-02
K791838 HSH/H512 ADULT PHYSIOLOGICAL MONITORS Medtel Pty. , Ltd. DSK Class II 1979-10-01
K791839 H59 CRITICAL CARE MONITOR Medtel Pty. , Ltd. DSK Class II 1979-10-01
K790775 INTRA-AORTIC BALLOON, TYPE S Datascope Corp. DSP Class II 1979-10-01
K790068 PULSE GENERATORS, MODELS 5983, 5989 Medtronic Vascular DXY Class III 1979-09-28
K791784 CORDIS BIPOLAR PACER CONNECTOR SYSTEM Cordis Corp. DXY Class III 1979-09-28
K791828 BJORK-SHILEY PULMONIC GRAFT VALVE Shiley, Inc. DSY Class II 1979-09-27
K791715 ARCOLITH 2000 Arco Medical Products Co. DXY Class III 1979-09-27
K791795 COMP-ACT IV Medcraft Corp. DPS Class II 1979-09-27
K791727 IMPLANTABLE VENTRICULAR-INHIBITED Telectronics, Inc. DXY Class III 1979-09-27
K791751 EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR Edwards Pacemaker Systems DXY Class III 1979-09-26
K791762 SELF CHECK Instromedix, Inc. DTC Class II 1979-09-21
K791181 PROGRAMMER, MEDTRONIC MODEL 5984/5985 Medtronic Vascular DXY Class III 1979-09-20
K790873 MODEL 221 PROGRAMALITH PULSE GENERATOR Pacesetter Systems DXY Class III 1979-09-20
K791568 IMPLANTABLE PULSE GENERATOR PACEMAKERS Intermedics, Inc. DXY Class III 1979-09-19
K791769 MEDTRONIC MODEL 6957 Medtronic Vascular DTB Class III 1979-09-19
K791380 VA 1000 Vitatron Medical BV DTA Class II 1979-09-19
K790143 VENTRICULAR LEAD, MODEL 6959 Medtronic Vascular DTB Class III 1979-09-19
K791732 IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC Oscor, Inc. DTB Class III 1979-09-19
K791201 SCINTISTRESS SYSTEM Cambridge Instruments, Inc. DPS Class II 1979-09-17
K791377 MODEL 484-01 BIPOLAR COAXIAL PACING LEAD Intermedics, Inc. DTB Class III 1979-09-12
K791637 TENS-O-TEST Curomatic, Inc. DXN Class II 1979-09-12
K791710 CARDIOVASCULAR INSTRUMENTS-VARIOUS Edward Weck, Inc. DWS Class I 1979-09-12
K791379 MODEL 228-02 THINLITH II PACEMAKER, BIPO Intermedics, Inc. DXY Class III 1979-09-12
K791378 MODEL 482-01 BIPOLAR COAXIAL PACING LEAD Intermedics, Inc. DTB Class III 1979-09-12
K791678 LITHICRON II 0403 IMPLANTABLE PACEMAKER Medcor, Inc. DXY Class III 1979-09-07
K791667 MEDTRONIC MODELS 69914/699OU Medtronic Vascular DTB Class III 1979-09-07
K791417 IMPLANTABLE PULSE GENERATOR PACEMAKER Intermedics, Inc. DXY Class III 1979-09-04
K791540 ELECTROCARDIOGRAPH MODEL ECG-5403 Nihon Kohden America, Inc. DPS Class II 1979-09-04
K791552 MODELS UL-804 AND BL-801 UNIPOLAR LEADS Pacesetter Systems DTB Class III 1979-09-04
K791430 MINIPRIME HYPOTHERMIC HEAT EXCHANGER Travenol Laboratories, S.A. DTR Class II 1979-08-28
K791498 ADAPTER-Y TYPE/CORONARY PERFUSION Dlp, Inc. DTL Class II 1979-08-28
K791421 MINISCOPE MS-2B ELECTROCARDIOSCOPE Renesco International, Inc. DPS Class II 1979-08-28
K791487 MODEL 78520A ARRHYTHMIA MONITORING SYS Hewlett-Packard Co. DSI Class II 1979-08-28
K791420 MINIGRAPH MG-I ELECTROCARDIOGRAPH Renesco International, Inc. DPS Class II 1979-08-28
K791424 DCG-VII ELECTROCARDIOSCANNER Del Mar Avionics DSI Class II 1979-08-28
K791225 BJORK-SHILEY AORTIC GRAFT VALVE PROSTH Shiley, Inc. DXY Class III 1979-08-10
K791095 LITHICRON MODEL 0401, PACEMAKER Medcor, Inc. DXY Class III 1979-08-10
K790218 BIPOLAR LEAD ADAPTOR, MODEL BA-415 Pacesetter Systems DTD Class II 1979-08-10
K791334 MULTISCOPE Amdia Medical Products DQD Class II 1979-08-10
K790141 PULSE GENERATOR, R WAVE DEMAND Pacesetter Systems DXY Class III 1979-08-10
K791333 BOWLES STETHOSCOPE Amdia Medical Products DQD Class II 1979-08-10
K790428 MDL-201A & T DL-201A PULSE GENERATOR Pacesetter Systems DXY Class III 1979-08-10
K791335 NURSESCOPE Amdia Medical Products DQD Class II 1979-08-10

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