meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
1991-02-15

Clearances · page 136 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K902256 IRRIGATION CATHETER 4, 6 AND 10 FRENCH Applied Vascular Devices, Inc. DQY Class II 1991-02-15
K904404 MULTI-LUMEN CENTRAL VENOUS CATHETER SET Arrow Intl., Inc. DQY Class II 1991-02-15
K904317 AVALON GENERAL PURPOSE SCANNER, PREVIEW GP Avalon Technology Corp. DPW Class II 1991-02-13
K905369 UST-2266U-5 CW DOPPLER TRANSDUCER Ge Medical Systems Information Technologies JOP Class II 1991-02-11
K905499 SCIMD 7 FR. TRIGUIDE GUIDING CATHETER Scimed Life Systems, Inc. DQO Class II 1991-02-11
K905729 CANMED 451 Andover Medical, Inc. DRX Class II 1991-02-07
K904696 WEP-8430A TELEMETRY CENTRAL STATION Nihon Kohden America, Inc. DRT Class II 1991-02-07
K905159 FLO-RESTER(R) VESSEL SIZER Bio-Vascular, Inc. DWP Class II 1991-02-07
K910155 SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH Scimed Life Systems, Inc. LIT Class II 1991-02-07
K905458 SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER Baxter Healthcare Corp DQE Class II 1991-02-07
K905720 PALMAZ BILIARY STENT Johnson & Johnson Interventional Systems DQY Class II 1991-02-05
K905446 MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE Medtronic Andover Medical, Inc. DRX Class II 1991-02-05
K904088 ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC Sentinel DQA Class II 1991-02-05
K905224 CARDIOPULMONARY BYPASS VASCULAR CATHETER 3M Health Care, Sarns DWF Class II 1991-02-05
K905547 SOFTOUCH GUIDING CATHETER Mallinckrodt Medical DQY Class II 1991-02-05
K905502 .010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP Advanced Cardiovascular Systems, Inc. DQX Class II 1991-02-04
K902999 VASCULAR RETRIEVAL FORCEPS Cook, Inc. DQY Class II 1991-02-01
K904491 TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 Lifestream Int'L, Inc. DQO Class II 1991-02-01
K905638 SARNS INVENT CATHETERS 3M Health Care, Sarns DWF Class II 1991-02-01
K905727 USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER C.R. Bard, Inc. DQO Class II 1991-02-01
K904690 TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM Marquest Medical Products, Inc. DWJ Class II 1991-02-01
K904575 MODEL 5866-37M LEAD ADAPTOR KIT Medtronic Vascular DTD Class II 1991-02-01
K905297 DIAVENTIONAL CATHETER Cordis Corp. DQO Class II 1991-02-01
K904512 TRACET AG 4000 Lectec Corp. DRX Class II 1991-01-31
K910029 PATIENT CARE MANAGEMENT SYSTEM MODIFICATION Spacelabs, Inc. DXK Class II 1991-01-31
K904466 MODEL #250 DEFIB CABLE Cardiotronics, Inc. LDD Class II 1991-01-30
K905773 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Mallinckrodt Medical LIT Class II 1991-01-30
K905674 LEAD STYLET Cardiac Pacemakers, Inc. DRB Class II 1991-01-30
K905432 DATASCOPE INTERLOCK GUIDE WIRE EXTENSION Datascope Corp. DQX Class II 1991-01-30
K903514 FUKUDA DENSHI MODEL LX-3100 Fukuda Denshi USA, Inc. DSI Class II 1991-01-30
K905189 BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) Baxter Healthcare Corp DQI Class II 1991-01-30
K904792 DIAGNOSTIC ULTRASOUND VERSADOPP 1000 Diagnostic Ultrasound Corp. DPW Class II 1991-01-28
K905008 FLEXIBLE INTRACARDIAC SUCTION DEVICE Gish Biomedical, Inc. DTS Class II 1991-01-23
K905568 TOPICAL COOLING PAD, MODEL 7000 Daily Medical Products, Inc. DTR Class II 1991-01-23
K903133 OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C Omron Marshall Products, Inc. DXN Class II 1991-01-18
K903186 OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE Telectronics Pacing Systems, Inc. DXY Class III 1991-01-18
K902159 BIFLEX(TM) ANNULOPLASTY RING St. Jude Medical, Inc. KRH Class II 1991-01-18
K903136 ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER Arzco Medical Electronics, Inc. DRF Class II 1991-01-18
K903917 COMPACT MONITOR SMK 210,211,230,231,240 Ppg Hellige B.V. DSP Class II 1991-01-18
K904255 FOCUS T41,T41F,T43, T43F,T44F Elamedical DTB Class III 1991-01-18
K902782 SERIES 1500 RESPONDER Marquette Electronics, Inc. LDD Class II 1991-01-18
K902674 DATASCOPE ARTERIAL CANNULA W/ACCESS PORT Datascope Corp. DQR Class II 1991-01-16
K904287 STEALTH DILATION CATHETER SYSTEM/MODIFICATION Target Therapeutics DYG Class II 1991-01-16
K904954 CONDOR DIGITAL INFLATION SYRINGE Professional Medical Services MAV Class II 1991-01-16
K903700 IPG-II MODULE Life Sciences Manufacturing, Inc. DSB Class II 1991-01-16
K904282 BIFURCATED GORE TEX STRETCH VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1991-01-16
K905018 LAB-SITE SAFETY NEEDLE Telos Medical Corp. DQO Class II 1991-01-16
K904994 CLOSED SYSTEM FLUSH SET Argon Medical Corp. DXT Class II 1991-01-15
K903344 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) Kontron Instruments, Inc. DSP Class II 1991-01-15
K905312 DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS Baxter Bentley Laboratories, Inc. DWF Class II 1991-01-15
K905311 DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. Baxter Bentley Laboratories, Inc. DWD Class II 1991-01-15
K904777 SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS Baxter Healthcare Corp DRS Class II 1991-01-15
K905100 HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST Hewlett-Packard Co. DQK Class II 1991-01-15
K905017 LAB-SITE Telos Medical Corp. DQO Class II 1991-01-15
K905856 MODEL 556 MONITOR Ge Medical Systems Information Technologies DSF Class I 1991-01-11
K904109 BIO-IMPEDANCE ANALYZER Xitron Technologies, Inc. DSB Class II 1991-01-08
K904741 LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES Telectronics Pacing Systems, Inc. DTB Class III 1991-01-08
K904739 DYNAPULSE 200M Pulse Metric, Inc. DXN Class II 1991-01-08
K903134 OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C Omron Marshall Products, Inc. DXN Class II 1991-01-08
K903900 SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. Ppg Hellige B.V. DSK Class II 1991-01-08
K905250 LOBOW Perinatal Systems LIT Class II 1991-01-08
K904941 MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE Cardiac Control Systems, Inc. DXY Class III 1991-01-03
K903463 IVT INTRODUCER SHEATH Intensive Technology, Inc. DYB Class II 1991-01-03
K903671 ATHANS EKG STANDARDIZER Advanced Medical Concepts, Inc. DPS Class II 1991-01-03
K904884 ACS URETHAN CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1991-01-03
K904275 MORSE BALLOON INFLATION DEVICE North American Instrument Corp. MAV Class II 1991-01-03
K904602 MEDTRONIC MODEL 5301B TEST CABLE Medtronic Vascular DXY Class III 1991-01-03
K904680 THERATEK GROUP EXCHANGE CATHETER Dow Corning Wright MCW Class II 1990-12-27
K904674 CENTRAL VENOUS PRESSURE MANOMETER Medex, Inc. KRK Class II 1990-12-27
K905147 ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS Hewlett-Packard Co. DXQ Class II 1990-12-27
K904039 REFLECTANCE SENSOR (RS-10) Nellcor, Inc. DQA Class II 1990-12-27
K896903 FIRST MEDIC MODEL 510 Spacelabs, Inc. LDD Class II 1990-12-27
K903925 ARIES MELDICAL MODEL 2100HC HANK CRANK Aries Medical, Inc. KFM Class II 1990-12-21
K904892 VACUUM BAKE CYCLE Medtronic Vascular DXY Class III 1990-12-20
K904353 CARDIOMATIC MODEL MSC-2001 Medical Systems Corp. DRT Class II 1990-12-20
K902650 BODYHEAT Medadvances, Inc. DWJ Class II 1990-12-20
K905101 NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF Hewlett-Packard Co. DXQ Class II 1990-12-20
K903621 MAGNUM-20 (TM) INFLATION DEVICE Vascumed Systems MAV Class II 1990-12-20
K905510 LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED Physio-Control Corp. LDD Class II 1990-12-20
K904318 LOCAL REPORT GENERATOR Spacelabs, Inc. DXN Class II 1990-12-18
K902404 SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW 3M Company KFM Class II 1990-12-17
K892671 WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER Wilson Biomedical, Inc. DQO Class II 1990-12-17
K902437 COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER Cobe Laboratories, Inc. DTP Class II 1990-12-17
K903491 MONITRODE Lleventon DRX Class II 1990-12-17
K904787 CRI STEERABLE CATHETER CONTROL SYSTEM Catheter Research C/O Burditt, Bowles & Radzius DXX Class II 1990-12-17
K900814 CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS Intellimetrics Instrument Corp. DQK Class II 1990-12-17
K902631 COBE ICU CONVERSION KIT Cobe Laboratories, Inc. DTN Class II 1990-12-17
K904788 MEWISSEN CATHETER Boston Scientific Corp DQO Class II 1990-12-17
K903199 HOLLOW LUMEN NEEDLE, PART NUMBER: MX920 Medex, Inc. DQO Class II 1990-12-17
K903632 INTERSEPT 1375 VENOUS RESERVOIR Medtronic Vascular DTN Class II 1990-12-17
K904601 ADVANCE DISPOSABLE PRESSURE TRANSDUCER Advance Medical Designs, Inc. DRS Class II 1990-12-17
K904944 TRANSLUMINAL ENDARTERECTOMY DEVICE Baxter Healthcare Corp DWX Class II 1990-12-17
K904959 PSG HEMOSTATIC CONTROL VALVE Peripheral Systems Group DQO Class II 1990-12-17
K902377 ANGEFLATOR(TM) Angeion Corp. DXT Class II 1990-12-13
K904758 CARDIOFAX ECG-8830A Nihon Kohden America, Inc. DPS Class II 1990-12-13
K902723 ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 Electromedics, Inc. DTM Class II 1990-12-13
K904476 VESSEL DILATOR Datascope Corp. DRE Class II 1990-12-10
K904171 SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM Scimed DTR Class II 1990-12-06
K904040 SOFTSHELL VENOUS RESERVOIR C.R. Bard, Inc. DTN Class II 1990-12-06
K904477 GUIDEWIRE Datascope Corp. DQX Class II 1990-12-06

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