meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
37
Latest Decision
1979-03-02

Clearances · page 187 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790246 SARNS WIRE-REINFORCED VENOUS RETURN CAN 3M Health Care, Sarns DWF Class II 1979-03-02
K790036 DIGITAL BPM Narco Air-Shields DXO Class II 1979-03-02
K790328 MODEL 1051, MONITOR Applied Medical Research DXN Class II 1979-03-02
K790203 INTERVAL TIMER MODEL V4295 Electronics For Medicine, Inc. DRR Class II 1979-03-02
K790004 MONITOR SCOPES, MODELS 9502, 9503 C-V Monitors Corp. DRT Class II 1979-02-28
K790287 ANALYZER, MEDILOG II Oxford Medilog, Inc. DSI Class II 1979-02-28
K790286 RECORDER, MEDILOG II Oxford Medilog, Inc. DSH Class II 1979-02-27
K790288 STORAGE, DIGITAL DSC-1, CONTROL UNIT Oxford Medilog, Inc. DXG Class II 1979-02-27
K790261 MEDTRONIC TEMPTRON Medtronic Vascular DTB Class III 1979-02-27
K790289 PB-4 REPLAY UNIT Oxford Medilog, Inc. DSH Class II 1979-02-27
K790276 MINILITH AND MICROLITH Cardiac Pacemakers, Inc. DXY Class III 1979-02-26
K790047 CARDIAC OUTPUT COMPUTER, MDEL 9520A Edwards Laboratories DXG Class II 1979-02-26
K790327 ANGIO-FLO Deseret Medical, Inc. KRA Class II 1979-02-26
K790292 MONITOR, ELECTROCARDIOSCOPE Burdick Corp. DRT Class II 1979-02-26
K782132 PLETHYSMOGRAPH, STRAIN GAUGE Medasonics, Inc. JOM Class II 1979-02-26
K790241 INTRA-AORTIC BALLOON-PUMP Avco Medical Products DSP Class II 1979-02-23
K790258 MOVABLE CORE SAFETY GUIDE Cordis Corp. DQX Class II 1979-02-23
K782073 DINAMAP MODELS 1160 AND 1165 Applied Medical Research DSK Class II 1979-02-23
K790144 TELEMETRY SYSTEM 315 Ge Medical Systems Information Technologies DRG Class II 1979-02-23
K782072 QUINTON STATUS 1000 Quinton, Inc. DQK Class II 1979-02-23
K790135 MONITOR, PRESSURVEIL Concept, Inc. DSK Class II 1979-02-13
K790116 CARDIOTOMY RESERVOIR CR-2000 Delta Medical Industries DTB Class III 1979-02-08
K790124 GRAFT TUNNELER Narco Scientific DWS Class I 1979-02-08
K790233 ELECTROCARDIOGRAPH, AT-300 3 CHANNEL Health Technology Laboratories, Inc. DPS Class II 1979-02-08
K781822 ELECTRODE, MODEL 030-324 Telectronics, Inc. DTD Class II 1979-02-08
K790014 BIPOLAR, STANICOR LAMBDA MODEL 236,235 Cordis Corp. DXY Class III 1979-02-08
K781823 ELECTRODE, MODEL 030-326 Telectronics, Inc. DTD Class II 1979-02-08
K790192 SARNO SINGLE POLE MAST Sames, Inc. KRI Class I 1979-02-08
K782149 PULSE GENERATOR, IMPLANTABLE CARDIAC Telectronics, Inc. DXY Class III 1979-02-08
K790114 ELECTROCARDIOGRAPH, EK-9 Burdick Corp. DPS Class II 1979-02-08
K781824 ELECTRODE, MODEL 030-324/4 GUAGE Telectronics, Inc. DTD Class II 1979-02-08
K781498 LIFELINE BIPOLAR PACING LEAD MOD. 466-01 Intermedics, Inc. DTB Class III 1979-02-01
K781497 LIFELINE PACING LEAD MODEL 465-01 Intermedics, Inc. DTB Class III 1979-02-01
K782079 ELECTRODE SYSTEM, QUIK-PREP Quinton, Inc. DRX Class II 1979-02-01
K790107 CATHETER TUBING MODIFICATION Jelco Laboratories DQO Class II 1979-02-01
K781525 ENDOCARIDAL PACING LEAD UNIPOLAR 477 Intermedics, Inc. DTB Class III 1979-02-01
K790034 INTRODUCERS Clincal Instruments Corp. DYB Class II 1979-02-01
K781570 SUTURELESS MUOCARDINE PACING LEADS 471 Intermedics, Inc. DTB Class III 1979-02-01
K781499 LIFELINE PACING LEAD MODEL 467-01 Intermedics, Inc. DTB Class III 1979-02-01
K781805 CARDIAC COMPUTERS, CO-10 & CO-10R Waters Assoc., Inc. DXG Class II 1979-01-29
K790082 ARTERIAL EXTENSION SET Namic DQO Class II 1979-01-25
K790083 CATHETER, ARTERIAL LINE Namic DQY Class II 1979-01-25
K790100 ISOLATION SLEEVE, MODEL 348-01 Intermedics, Inc. DXY Class III 1979-01-24
K790099 ISOLATION SLEEVE, MODEL 347-01 Intermedics, Inc. DXY Class III 1979-01-24
K790098 ISOLATION SLEEVE, MODEL 349-01 Intermedics, Inc. DXY Class III 1979-01-24
K790101 ISOLATION SLEEVE, MODEL 346-01 Intermedics, Inc. DXY Class III 1979-01-24
K782095 STOPCOCKS, MANIFOLDS Namic DTL Class II 1979-01-23
K781848 PUMP, BALLOON MODEL 10 Avco Medical Products DSP Class II 1979-01-23
K790022 DISPOSABLE HOLDER FOR BIOPROSTHESIS Edwards Laboratories DTJ Class I 1979-01-15
K782131 PULSETAKER Van, Cott, Bagley, Cornwall & Mccarth DRT Class II 1979-01-15
K782087 LEAD, SUTURELESS MYOCARDIAL Daig Corp. DTB Class III 1979-01-15
K781819 POST EXTRA SYSTOLIC POTENTIATOR Medrad, Inc. DQO Class II 1979-01-15
K781517 AUTOMATIC BLOOD PRESSURE DEVICE Welch Allyn, Inc. DXN Class II 1979-01-11
K781879 HEATER, OXIMETER SYSTEM Oximetrix, Inc. DQA Class II 1979-01-08
K781855 LVV OPTION Honeywell, Inc. DXG Class II 1979-01-05
K781867 WRITER, GEMINI-3 C-V Monitors Corp. DSF Class I 1979-01-05
K781873 RECORDER, STRIP CHART WITH PRINTER Midwest Analog & Digital, Inc. DSF Class I 1979-01-05
K782088 MONITOR, HEART RATE MODEL 105 Roche Medical Electronics, Inc. DRT Class II 1979-01-04
K782089 MONITOR, HEART RATE MODEL 103 Roche Medical Electronics, Inc. DRT Class II 1979-01-04
K782108 MEDTRONIC MODEL 546 Medtronic Vascular DTE Class II 1978-12-29
K782076 HT-110 MICROMINI Health Tech DXH Class II 1978-12-29
K782146 PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT Arco Medical Products Co. DXY Class III 1978-12-27
K782023 MICROLITH A MODEL 803 Cardiac Pacemakers, Inc. DXY Class III 1978-12-22
K782097 ELECTRODE LEAD MODEL 030-198 Telectronics, Inc. DTD Class II 1978-12-22
K782022 MICROLITH A MODEL 703 Cardiac Pacemakers, Inc. DXY Class III 1978-12-22
K780430 LITHICRON F PROGRAMMABLE PULSE GEN Medcor, Inc. DXY Class III 1978-12-22
K781624 PACING LEAD MODEL BUS 860, BUS 890 R.E. Brown Co., Inc. DTB Class III 1978-12-21
K782059 TRANSMITTER, TR-1 ECG Burdick Corp. DXH Class II 1978-12-21
K781835 PULSTRON MODEL 100 Micro-Rel DXY Class III 1978-12-21
K782082 CATHETER, DIGITAL POSITRAL II C.R. Bard, Inc. DQO Class II 1978-12-20
K781864 ADAPTER KIT Daig Corp. DTD Class II 1978-12-19
K781963 ELECTRODES, OFFSET AND DX Graphic Controls Corp. DRX Class II 1978-12-19
K782004 LEAD, TIMED PACING, IMPLANTABLE Daig Corp. DTB Class III 1978-12-15
K782071 CATHETER, USCI GRUNTZIG/BALLOON C.R. Bard, Inc. DYG Class II 1978-12-15
K782033 CARDIAC CARE Q/C TEST KIT Instrumentation Laboratory CO DRL Class II 1978-12-15
K781986 TRANSMITTER, MODEL 9406 AND 9401 Medtronic Vascular DXH Class II 1978-12-13
K781679 MONITOR/MINI SCOPE Ipco Corp. DPS Class II 1978-12-12
K781678 DEFIBRILLATOR, MARK II Ipco Corp. LDD Class II 1978-12-12
K781327 PULSE GENERATOR, MODEL 240, EXTERNAL Intermedics, Inc. DTE Class II 1978-12-11
K781625 PACING LEAD MODEL MVM 860, MVM 890 R.E. Brown Co., Inc. DTB Class III 1978-12-08
K781619 PACING LEAD MODELS SA, 350, SAM 500 R.E. Brown Co., Inc. DTB Class III 1978-12-08
K781623 PACING MODELS MUM 860, MUM 890 R.E. Brown Co., Inc. DTB Class III 1978-12-08
K781626 PACING LEAD ADAPTER, ACV 14, ACV 23 R.E. Brown Co., Inc. DTD Class II 1978-12-08
K781622 PACING LEAD ADAPTER MODEL ACS 16 R.E. Brown Co., Inc. DTD Class II 1978-12-08
K781621 PACING LEAD MODELS, MAM 1260 MAM 1290 R.E. Brown Co., Inc. DTB Class III 1978-12-08
K781627 PACING LEAD ADAPTER MODEL ADB 21 R.E. Brown Co., Inc. DTD Class II 1978-12-08
K781620 PACING LEAD MODELS, MDM 1060, MDM 1090 R.E. Brown Co., Inc. DTB Class III 1978-12-08
K781738 PACEMAKER, MODEL 229-01 Intermedics, Inc. DXY Class III 1978-12-07
K780897 GENERATOR, PULSE, SORIN MODEL DL-1 Bentley Laboratories, Inc. DXY Class III 1978-12-06
K782000 MONITOR, NON-INVASIVE BLOOD PRESSURE Automated Screening Devices DXN Class II 1978-12-05
K781326 UNIPOPLAR ENDOCARDIAL LEADS American Technology, Inc. DTB Class III 1978-12-04
K781701 BLOOD PRESSURE, DIGITAL MODEL #2153 Sears, Roebuck & Co. DSK Class II 1978-12-04
K781990 CARDIAC INSULATION PAD Shiley, Inc. DWF Class II 1978-12-04
K781890 CHAMBER, MC-1 DISPOSABLE PRESSURE Delta Medical Industries DXS Class II 1978-12-04
K781849 ELECTRODES, IMPLANTABLE WITH ADAPTER Telectronics, Inc. DTB Class III 1978-12-04
K781456 ENDOCARDIAL BIPOLAR LEAD American Technology, Inc. DTB Class III 1978-12-04
K781377 OVALITH 10BP Coratomic, Inc. DXY Class III 1978-12-04
K781764 PAD, COOLING #27-999 Cobe Laboratories, Inc. DTR Class II 1978-12-04
K781836 TELEMETRY SYSTEM, BIOTEL 300 Spacelabs, Inc. DRG Class II 1978-12-04
K781002 TEMPORARY CARDIAC PACING WIRE ETHICON, Inc. LDF Class II 1978-12-04

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