meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1977-11-22

Clearances · page 190 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K772097 HEARTRATE METER MODEL 650, P/N 000119 Quinton, Inc. DRT Class II 1977-11-22
K772158 LIGHT-PEN SYSTEM FOR QUANTI. ANALY. Varian Assoc., Inc. DXG Class II 1977-11-22
K772056 PHYSIOLOGICAL MONITOR MODEL 871 Datascope Corp. DRT Class II 1977-11-22
K772137 VEIN CLAMPS A&A Ent. DXC Class II 1977-11-21
K772103 BIPOLAR LEADS, DISP. Medtronic Vascular DTB Class III 1977-11-21
K772093 IMPEDANCE RHEOGRAPH Dynatech Research & Development Co. DQB Class II 1977-11-18
K772092 CHEST FLUID MONITOR Dynatech Research & Development Co. DSB Class II 1977-11-18
K771810 PRESSURE TUBING Pharmaseal Div., Baxter Healthcare Corp. DQO Class II 1977-11-17
K770937 PUMP, BYPASS, PULSATILE, AVCO Avco Medical Products KFM Class II 1977-11-17
K772059 CATHETER, PACING/MONITORING Electro-Catheter Corp. DYG Class II 1977-11-15
K772015 PATIENT HEATER SYSTEM, MODEL PH112 Carolina Medical Electronics DWJ Class II 1977-11-15
K771393 ELHCTRONIC SPHYGMOMANOMETER C.R. Bard, Inc. DXN Class II 1977-11-11
K772053 LINE CHARGER MODEL LC-100 Datascope Corp. DRT Class II 1977-11-09
K771776 ECG CLUSTER ELECTRODE C.R. Bard, Inc. DRX Class II 1977-11-09
K771976 ECG AMPLIFIER/R WAVE TRIGGER G.D. Searle and Co. DRR Class II 1977-11-09
K771394 ELECTRONIC STETHESCOPE C.R. Bard, Inc. DXN Class II 1977-11-09
K772027 CARDIOCASSETTE II Cardiodyne, Inc. DSH Class II 1977-11-09
K772048 SINGLE & DUAL CHANNEL RECORDER Hewlett-Packard Co. DSF Class I 1977-11-09
K771932 RECORDER, DINMAP, MODEL 950 Applied Medical Research DSH Class II 1977-11-07
K772026 CARDIAC PULSE GENERATOR, MODEL 150L Telectronics, Inc. DXY Class III 1977-11-03
K771380 ELAPSED TIME INDICATOR MODEL 21361A Hewlett-Packard Co. DPS Class II 1977-11-03
K772058 LEAD ADAPTOR KIT MODEL 5866-21 Medtronic Vascular DTD Class II 1977-11-03
K771991 CARDIAC OUTPUT THERMODILUTION MODULE Abbott Laboratories DXG Class II 1977-11-03
K772057 BIPOLAR PACEMAKER MODEL 224 Intermedics, Inc. DXY Class III 1977-11-03
K771992 L-501 CARDIAC PACEMAKER Coratomic, Inc. DXY Class III 1977-11-02
K771982 888 ARTERIAL/VENOUS CATHETER INTRODUCER Usci, Div. C.R. Bard, Inc. DYB Class II 1977-11-02
K772021 TRC STAINLESS STEEL SAFETY SPRING GUIDES Usci, Div. C.R. Bard, Inc. DQX Class II 1977-11-02
K772001 SARNES HELP 3M Health Care, Sarns DTQ Class II 1977-11-02
K771987 MICROPULSE 26U PULSE GENERATOR Edwards Pacemaker Systems DXY Class III 1977-11-02
K771922 MINICLINIC TM Instromedix, Inc. DTC Class II 1977-11-02
K771931 MONITOR, DINMAP, MODEL 850 Applied Medical Research DXN Class II 1977-10-27
K771897 DINAMAP MODEL 837 Applied Medical Research DXN Class II 1977-10-25
K771895 DINAMAP MADEL 845 Applied Medical Research DXN Class II 1977-10-25
K771896 DINAMAP MODEL 835 Applied Medical Research DXN Class II 1977-10-25
K771819 CABG RINGS A&A Ent. DSY Class II 1977-10-21
K771645 ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE Tronomed, Inc. DSA Class II 1977-10-18
K771855 OMNICOR PROGRAMMER MODEL 222A Cordis Corp. KRG Class III 1977-10-07
K770835 PATCH FABRIC Usci, Div. C.R. Bard, Inc. DXZ Class II 1977-10-05
K771692 TUBING SETS Cobe Laboratories, Inc. DWF Class II 1977-10-04
K771772 DINAMAP MODEL 825A Applied Medical Research DSK Class II 1977-10-04
K771782 DINIMAP MODEL 827A Applied Medical Research DXN Class II 1977-10-04
K771764 CORONARY PRESSURE PERFUSION PUMP 3M Health Care, Sarns DXS Class II 1977-09-30
K771666 SPHYGMOMANOMETER #1235 Sears, Roebuck & Co. DXG Class II 1977-09-30
K771750 RF CHOKE CABLE C.R. Bard, Inc. DSA Class II 1977-09-30
K771718 CARDIOTHERM-500X Columbus Instruments Intl. Corp. DXG Class II 1977-09-28
K771520 ESOPHAGEAL STETHOSCOPE Labarge, Inc. DQD Class II 1977-09-23
K771648 COMPUTER ECG TERMINAL Compumed, Inc. DXH Class II 1977-09-20
K771663 PROBE & CATHETER Edwards Laboratories KRB Class II 1977-09-20
K771668 DISP. FLUID ISOLATOR & PRESS. RELIEF Ailtech DRS Class II 1977-09-14
K771641 UNIVERSAL LEAD ADAPTER, UA-414 Pacesetter Systems DTD Class II 1977-09-14
K771685 AMPLIFIER MODEL N5A-HIS Honeywell, Inc. DRJ Class I 1977-09-14
K771642 ADAPTER A-413 Pacesetter Systems DTD Class II 1977-09-14
K771566 ENDOCAR. PACING LEAD-STD. LENGTH PL202 Daig Corp. DTB Class III 1977-09-14
K771564 ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100 Daig Corp. DTB Class III 1977-09-14
K771567 ENDOCARD. PACING LEAD-LONG LENGTH PL203 Daig Corp. DTB Class III 1977-09-14
K771565 ENDOCARD. PACIN/ LEAD-LONG LENGTH PL200 Daig Corp. DTB Class III 1977-09-14
K771306 THERMOCATH Victory Engineering Corp. DYG Class II 1977-09-14
K771684 AMPLIFIER MODEL N5A-ECG Honeywell, Inc. DRJ Class I 1977-09-14
K771626 PACEMAKER MODEL 251 Intermedics, Inc. DXY Class III 1977-09-12
K771653 ELECTRONIC STETHOSCOPE 3M Company DQD Class II 1977-09-12
K771670 IMPLANTED PACEMAKER PLUSE GENERATOR Telectronics, Inc. DXY Class III 1977-09-12
K770956 PAS ANTI-EMBOLISM SYSTEM Hamilton Industries, Inc. JOW Class II 1977-09-12
K771625 LEININGEO AORTIC PUNCH #310-395 & 397 J. Jamner Surgical Instruments, Inc. DWS Class I 1977-09-12
K771537 AQUAMATIC K-MODULE MODEL K-20 Gorman Rupp Industries DWJ Class II 1977-09-06
K771449 ARTEOIAL TONOMETER ML-105 Nicolet Biomedical Instruments DXN Class II 1977-09-06
K771501 ANEROID SPHYGMOMETER Swartz Medical Equipment DXQ Class II 1977-08-30
K771572 PATIENT MONITORS MODELS 78701A/78702A Hewlett-Packard Co. DRR Class II 1977-08-30
K771504 STETHOSCOPE Swartz Medical Equipment DQD Class II 1977-08-26
K771581 STETHOSCOPE, NURSESCOPE TYPE Swartz Medical Equipment DQD Class II 1977-08-26
K771505 STETHOSCOPE Swartz Medical Equipment DQD Class II 1977-08-26
K771506 STETHOSCOPE Swartz Medical Equipment DQD Class II 1977-08-26
K771538 LITHICRON MODEL 3-70C-B PULSE GENERATOR Medcor, Inc. DXY Class III 1977-08-22
K771292 HIGH-SPEED SECTOR SCANNING SSL-52H Toshiba Medical Systems DXK Class II 1977-08-16
K771230 PERCUTANEOUS INTRODUCER SHEATH SET Medical Disposables Intl., Inc. DQX Class II 1977-08-16
K771528 CATHETER, CARDIAC PACING, ENDOCARDIAL American Technology, Inc. DTB Class III 1977-08-16
K771231 ARTEOIAL LINE KIT Medical Disposables Intl., Inc. DQX Class II 1977-08-16
K771392 ACCU-TRODE (DISP. ECG ELECTRODE) Warner/Chilcott DRX Class II 1977-08-16
K771500 PRESSUROMETER II Del Mar Avionics DXN Class II 1977-08-16
K771261 ADVANSET C.R. Bard, Inc. DRC Class II 1977-08-16
K771499 FLEXIBLE ARTERIAL CANNULAE 3M Health Care, Sarns DWF Class II 1977-08-16
K770720 TUBING PACK, EXTRACORPOREAL, H-3000 William Harvey Life Products Corp. BYS Class II 1977-08-04
K771360 ECG SCOPE MODEL 7833 Hewlett-Packard Co. DRT Class II 1977-08-04
K771447 PREGELLED DISP. EKG MONITORING ELECT- Hayes Products, Inc. DRX Class II 1977-08-04
K771374 SCANNER TREND SYSTEM Instruments For Cardiac Research DSI Class II 1977-08-04
K771372 SYSTEM II Irex Corp. DSF Class I 1977-08-04
K771361 PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A Hewlett-Packard Co. DRS Class II 1977-08-04
K771199 SURGIPULSE HEART RATE MONITOR Stryker Corp. DRT Class II 1977-07-25
K771083 SEQUENTIAL PRESSURE CUFF Gaymar Industries, Inc. JOW Class II 1977-07-21
K771262 PACEMAKER & CARDIAC LEAD, BIPOLAR Arco Medical Products Co. DXY Class III 1977-07-21
K771041 INTRODUCER, CAT. #INT-06FR. Sorensen Research DYB Class II 1977-07-13
K771042 INTRODUCER, CAT. #INT-05FR. Sorensen Research DYB Class II 1977-07-13
K770946 RECORD, MODEL 702, I.L. Instrumentation Laboratory CO DSF Class I 1977-07-05
K771027 ELECTROCARDIOGRAPHIC PATIENT CABLES Tronomed, Inc. DSA Class II 1977-07-05
K771040 INTRODUCER, CAT. #INT-07FR. Sorensen Research DYB Class II 1977-06-29
K770868 CATHETER, POLYURETHANE, W/STYLET Abbott Laboratories DQO Class II 1977-06-27
K771046 VENA CAVA UMBRELLA FILTER, MODEL 7321 Edwards Laboratories DTK Class II 1977-06-22
K771026 HUANG VEIN HOLDER, #21-8011 Codman & Shurtleff, Inc. DWS Class I 1977-06-20
K770880 GENERATOR, PULSE, UNIPOLAR, #508 Cardiac Pacemakers, Inc. DXY Class III 1977-06-20
K770881 GENERATOR, PULSE, BIPOLAR 3608 Cardiac Pacemakers, Inc. DXY Class III 1977-06-20
K770951 CARDIAC PACERS W/NARROW PULSE WIDTH Cordis Corp. DXY Class III 1977-06-20

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