meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1988-07-14

Clearances · page 148 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881831 WS 800R THERMAL ARRAY RECORDER Nihon Kohden America, Inc. DSF Class I 1988-07-14
K873316 BUBBLE TRAP-FILTER CAT. NO B180F37 American Omni Medical, Inc. DTM Class II 1988-07-14
K874938 PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 Sp Innovations, Inc. DSB Class II 1988-07-12
K881273 HORIZON 2000 ARRHYTHMIA MONITORING OPTION Mennen Medical, Inc. DSI Class II 1988-07-12
K882045 HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK Cordis Leads, Inc. LDF Class II 1988-07-12
K882513 MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR Cardiac Resucitator Corp. DSI Class II 1988-07-12
K881986 ESCORT - PORTABLE PATIENT MONITOR Medical Data Electronics DXH Class II 1988-07-12
K881733 SHILEY FEMORAL CORONARY PERFUSION CATHETER Shiley, Inc. DWF Class II 1988-07-06
K881734 SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER Shiley, Inc. DWF Class II 1988-07-05
K881717 PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) Buckman Co., Inc. DWS Class I 1988-07-05
K881691 PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA Shiley, Inc. DWF Class II 1988-07-05
K881448 #557 DISPOSABLE CARDIOVASCULAR CLAMP Alpha Industries, Inc. DXC Class II 1988-06-30
K875160 RIGEL MODEL MULTICARE 409 Rigel Medical Electronics, Inc. DRT Class II 1988-06-28
K881504 VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT Hdc Corp. DQY Class II 1988-06-22
K881447 METATECH METAL MICROCLIP Metatech Corp. DXC Class II 1988-06-22
K881272 ACCUSTAT MODEL 102 NON-INVASIVE BLOOD MONITORING Accustat, Inc. DXN Class II 1988-06-22
K881322 MINI-TEMP(TM) Seabrook Medical Systems, Inc. DWJ Class II 1988-06-22
K872048 TRANSONIC FLOWMETER Transonic Systems, Inc. DPW Class II 1988-06-21
K882121 C-FLO SUCTION TUBE Concept, Inc. DXQ Class II 1988-06-20
K881158 VASCULAR CLAMP T. Korossurgical Instruments Corp. DXC Class II 1988-06-20
K880258 WITT BIOMEDICAL VX-80 Witt Biomedical Corporation DXG Class II 1988-06-16
K881269 OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C Omron Electronics, Inc. DXN Class II 1988-06-16
K874366 ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 Cordis Leads, Inc. DTB Class III 1988-06-16
K881602 OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C Omron Tateisi Electronics Co. DXN Class II 1988-06-15
K880696 MX1002 CABLE-CAL TM Medex, Inc. DXG Class II 1988-06-15
K874148 MONITRON SYSTEM American Health Products, Inc. DRT Class II 1988-06-15
K881455 EMBOLECTOMY CATHETER(MODIFIED) Cathlab Corp. DXE Class II 1988-06-15
K880926 BIOLOGICAL OHM METER, BES 200Z Bioelectrical Sciences, Inc. DSB Class II 1988-06-15
K881601 OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C Omron Tateisi Electronics Co. DXN Class II 1988-06-15
K881449 EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 Baxter Healthcare Corp LXN Class I 1988-06-15
K873764 AMBULATORY BLOOD PRESSURE MONITOR Pulsetrend, Inc. DXN Class II 1988-06-10
K880289 DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL Datascope Corp. DSP Class II 1988-06-10
K880041 VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT D-R Medical Systems, Inc. DSY Class II 1988-06-10
K881330 COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK Cobe Laboratories, Inc. DWF Class II 1988-06-10
K881073 SHILEY FEMORAL CANNULAE INTRODUCER KIT Shiley, Inc. DRE Class II 1988-06-09
K874165 DISPOSABLE CATHETER PRESSURE TRANSDUCER Deseret Medical, Inc. DXO Class II 1988-06-09
K881346 LIFESTAT 1600 PRINTER Physio-Control Corp. DSF Class I 1988-06-09
K880040 VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT D-R Medical Systems, Inc. DSY Class II 1988-06-09
K881352 RIGHT ATRIAL CATHETER INSERTION TRAY Quinton, Inc. DWF Class II 1988-06-09
K880879 WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION Ppg Industries, Inc. DQK Class II 1988-06-02
K873214 APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300 General Electric Co. DPT Class II 1988-06-01
K874138 ACCUCOM 2 Datascope Corp. DPT Class II 1988-06-01
K874664 IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 Telectronics, Inc. DTB Class III 1988-05-31
K881074 SHILEY FEMORAL VENOUS CANNULA Shiley, Inc. DWF Class II 1988-05-31
K875158 ACS FUNNEL INTRODUCER Advanced Cardiovascular Systems, Inc. DYB Class II 1988-05-31
K881392 CARDICAD(TM) Medical/Surgical Specialties, Ltd. DWS Class I 1988-05-31
K881521 MODIFIED SERVO SYRINGE Engineering, Inc. DXT Class II 1988-05-31
K880877 CONTRAST INJECTION DEVICE Med-West, Inc. DXT Class II 1988-05-31
K881072 SHILEY FEMORAL ARTERIAL CANNULA Shiley, Inc. DWF Class II 1988-05-31
K881088 ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) Devices For Vascular Intervention, Inc. LIT Class II 1988-05-31
K875167 HORIZON 9000 Mennen Medical, Inc. DXG Class II 1988-05-31
K881770 EPICARDIA LE/FD Medicomp, Inc. DQK Class II 1988-05-31
K881283 MEADOX INTRA-AORTIC GRAFT Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1988-05-26
K881711 VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. Telectronics and Cordis Pacing Systems DXY Class III 1988-05-26
K880860 CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 Dlp, Inc. DQT Class II 1988-05-26
K875178 MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. DTB Class III 1988-05-25
K880231 MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER Ideas For Medicine, Inc. DQT Class II 1988-05-25
K875337 HEPARIN COATED LUMINAL PACING CATHETER Spectramed, Inc. DQO Class II 1988-05-25
K881508 OCHSNER & MICRON FABRIC PATCH Intervascular, Inc. DXZ Class II 1988-05-25
K874465 SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD Abbott Laboratories DYG Class II 1988-05-25
K881712 MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT Medtronic Vascular DTB Class III 1988-05-25
K875100 MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. DTB Class III 1988-05-24
K880887 NEOCATH Taris Corp. DWF Class II 1988-05-24
K880777 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM Medsurg Industries, Inc. DWF Class II 1988-05-24
K881006 STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 Shiley, Inc. DRY Class II 1988-05-24
K871442 BIOSOUND MMI ULTRASOUND Biosound, Inc. JOP Class II 1988-05-20
K881356 EXTERNAL PACEMAKER WIRE DRESSING CHANGE Neal & Assoc., Inc. LDF Class II 1988-05-19
K881328 MODEL 375 ECG Birtcher Corp. DPS Class II 1988-05-18
K875036 INTRA-AORTIC BALLOON PUMP MODEL KAAT Kontron Instruments, Inc. DSP Class II 1988-05-18
K881279 EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET Baxter Healthcare Corp DTI Class I 1988-05-18
K881003 DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 Healthcheck Corp. DXN Class II 1988-05-18
K881732 GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DYF Class II 1988-05-18
K881136 HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI. Hewlett-Packard Co. DQA Class II 1988-05-18
K880167 GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1988-05-18
K881643 BATTERY PACKS FOR CARDIOVASCULAR UNITS Dowit Service Co., Inc. MHX Class II 1988-05-17
K881197 SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER Schneider-Shilley (Usa) LIT Class II 1988-05-16
K875118 PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 Bloodflow Laboratory, Inc. JOM Class II 1988-05-16
K880927 VASCU-CARE ANGIOSCOPE Vascu-Care, Inc. DQX Class II 1988-05-16
K880987 INJECTOR HANDLE WITH SYRINGE Applied Vascular Devices, Inc. DXT Class II 1988-05-13
K880615 AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30 Cardiotechnics, Inc. DXH Class II 1988-05-13
K880498 RM-301 PATIENT MONITOR Ppg Industries, Inc. DRT Class II 1988-05-13
K880533 VITEL III CM Equimed Corp. DXH Class II 1988-05-13
K874839 STAT-SAT Gish Biomedical, Inc. DRY Class II 1988-05-13
K880300 CARDIOBEEPER(R) III Survival Technology, Inc. DXH Class II 1988-05-12
K880780 HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG First Medical Devices Corp. DRL Class II 1988-05-12
K880663 SHILEY BCD PLUS HEAT EXCHANGER Shiley, Inc. DTR Class II 1988-05-11
K880781 DATALOGGER CHART RECORDER Air-Shields, Inc. DSF Class I 1988-05-11
K874861 ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. Acuson Computed Sonography DPT Class II 1988-05-11
K880572 OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR Ohmeda Medical DXN Class II 1988-05-10
K880831 LARGE LUMEN Y ADAPTER W/ROTATING DEVICE Interventional Medical, Inc. DTL Class II 1988-05-10
K874917 PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM Oxford Medilog, Inc. DXN Class II 1988-05-10
K880715 (MB-650) BLOOD PRESSURE MONITOR Sharp Electronics Corp. DXN Class II 1988-05-09
K880779 MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY Medsurg Industries, Inc. DWF Class II 1988-05-09
K880595 HORIZON 2000/S 266-XXX-XXX Mennen Medical, Inc. DPS Class II 1988-05-06
K880898 MULTICOR AND PACEMAKERS Tpl-Cordis, Inc. DXY Class III 1988-05-06
K880672 SENTINEL PULSE OXIMETER Sentinel Monitoring Technologies, Ltd. DQA Class II 1988-05-06
K880671 MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER Medtronic Blood Systems, Inc. DTM Class II 1988-05-06
K880554 VSM(R) R2 PAPER CHART RECORDER Physio-Control Corp. DSF Class I 1988-05-06
K880771 MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM Medsurg Industries, Inc. DQR Class II 1988-05-03
K874738 10 AND 12 FRENCH VESSEL DILATORS Impra, Inc. DRE Class II 1988-05-02

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