meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
1998-03-04

Clearances · page 110 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974546 BIOSENSOR HOLTER MONITOR SYSTEM Biosensor Corp. DQK Class II 1998-03-04
K974192 BIOSENSOR HOLTER MONITOR SYSTEM Biosensor Corp. DQK Class II 1998-03-04
K974034 PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. DRO Class II 1998-03-02
K972321 S3 MAST PUMP Stoeckert Instrumente DWB Class II 1998-02-27
K971619 MICROFUSE MEMBRANE INFUSION CATHETER E-Med Corp. KRA Class II 1998-02-27
K974067 FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE Merit Medical Systems, Inc. QEY Class II 1998-02-27
K974492 SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS Siemens Medical Solutions USA, Inc. MLD Class II 1998-02-26
K973011 BPX80 BIO-PUMP (BPX80) Medtronic Bio-Medicus, Inc. KFM Class II 1998-02-25
K972798 DYNEMO 3000 Sometec, Inc. DPW Class II 1998-02-24
K974559 SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. DQO Class II 1998-02-23
K972814 LOCATOR MODEL 4036 Pacesetter, Inc. DTB Class III 1998-02-23
K973080 SURGICAL VASCULAR CLAMP Walter Lorenz Surgical, Inc. DXC Class II 1998-02-23
K972795 CARDIO-CARD MANAGEMENT SYSTEM II Nasiff Assoc., Inc. DXN Class II 1998-02-20
K973962 BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS C.R. Bard, Inc. DSP Class II 1998-02-19
K973318 MOBIMED SYSTEM, (PEGASUS AND POLARIS) Ortivus Us, Inc. MSX Class II 1998-02-19
K974684 SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. DQY Class II 1998-02-19
K973465 LATIS GRAFT CLEANING CATHETER Applied Medical Resources DXE Class II 1998-02-19
K974420 M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION Hewlett-Packard Co. DSH Class II 1998-02-19
K973760 AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE Avecor Cardiovascular, Inc. DTZ Class II 1998-02-18
K972498 OBSERVER * CENTRAL STATION Johnson & Johnson Medical, Inc. DSI Class II 1998-02-17
K974335 EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. J-Lloyd Medical, Inc. DXE Class II 1998-02-13
K974318 HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB Healthcare Service and Supply JOW Class II 1998-02-13
K970229 ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET Arrow Intl., Inc. DYB Class II 1998-02-13
K972512 SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL Boston Scientific Scimed, Inc. LIT Class II 1998-02-12
K970358 ENSEMBLE CENTRAL STATION MONITOR Mennen Medical, Inc. DSI Class II 1998-02-11
K974247 40 CC GRANDE Boston Scientific Corp DSP Class II 1998-02-10
K973663 PALJET-B Golden Gate Bio-Device DRX Class II 1998-02-10
K974222 CES MASSTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 1998-02-10
K972740 HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01) Himex Production Corp. KFM Class II 1998-02-06
K973669 THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) Micro Therapeutics, Inc. MCW Class II 1998-02-06
K974448 CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM Cordis Corp. DYB Class II 1998-02-06
K974101 DATEX-ENGSTROM NETWORK Datex-Engstrom, Inc. MSX Class II 1998-02-06
K970445 VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300 Pace Tech Medical Monitors, Inc. MHX Class II 1998-01-30
K971670 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER Galix Biomedical Instrumentation, Inc. DSH Class II 1998-01-29
K973267 TTM5000 TELEPHONIC EKG MONITOR Hds Medical, Inc. DXH Class II 1998-01-29
K965106 ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 Biotronik, Inc. DTB Class III 1998-01-27
K974085 COBE OXYGENATOR PRODUCTS Cobe Cardiovascular, Inc. DTZ Class II 1998-01-27
K974621 PERCUPUMP II WITH EDA E-Z-Em, Inc. DSB Class II 1998-01-27
K963903 BIOSPECTROMETER-NB OXIMETER IIII Hutchinson Technology, Inc. MUD Class II 1998-01-27
K965153 HUNTLEIGH FP5000 SYSTEM MODEL FP5000 Huntleigh Healthcare, Inc. JOW Class II 1998-01-26
K965209 ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) Arrow Intl., Inc. DSP Class II 1998-01-23
K974079 FORMULA FOR ARCHIMED Biosound Esaote, Inc. DPS Class II 1998-01-22
K974155 BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT Baxter Healthcare Corp DTN Class II 1998-01-22
K974567 HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER Hewlett-Packard Co. MSX Class II 1998-01-20
K972242 REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM Medtronic Vascular MXC Class II 1998-01-16
K974061 RECHARGEABLE BATTERY PART NUMBER GL825-200 Alexander Mfg. Co. DXN Class II 1998-01-16
K973991 METRON QA-510 SPO2 ANALYZER Metron U.S., Inc. DQA Class II 1998-01-16
K973918 NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES Nihon Kohden America, Inc. DRT Class II 1998-01-13
K972572 SINGLE LUMEN EMBOLECTOMY CATHETER American Biomed, Inc. DXE Class II 1998-01-13
K972535 MAGLIFE C Odam MHX Class II 1998-01-13
K970922 JOBST ATHROMBIC PUMP/SLEEVE Jobst A Beiersdorf Co. JOW Class II 1998-01-13
K973945 LUGE GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1998-01-12
K973132 EZ HOLD 1 LBS., EZ HOLD 2 LBS Tz Medical, Inc. DXC Class II 1998-01-12
K973486 LIFE PAK 12 Physio-Control Corp. MKJ Class III 1998-01-09
K973887 MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 1998-01-08
K974149 AMBULATORY X-12 TELEMETRY MODULE Mortara Instrument, Inc. DRG Class II 1998-01-08
K972574 STELA MODEL UJ45 PACING LEADS Ela Medical, Inc. DTB Class III 1998-01-08
K973845 CORDIS HYDRONOL STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1998-01-05
K973863 MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR Hi-Tronics Designs, Inc. DXH Class II 1998-01-02
K970629 TANGO NON-INVASIVE BLOOD PRESSURE MONITOR Suntech Medical Instruments, Inc. DXN Class II 1998-01-02
K971696 SENTINEL RECORDER, MODELS 471/472 Del Mar Avionics DXH Class II 1997-12-30
K971775 INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 Cardiac Control Systems, Inc. LDF Class II 1997-12-29
K971570 EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 Quinton Electrophysiology Corp. DRR Class II 1997-12-29
K973873 DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 American Telecare, Inc. DRG Class II 1997-12-29
K973708 TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL Merit Medical Systems, Inc. DQX Class II 1997-12-19
K971086 RADIAL AND FEMORAL ARTERY CATHETER B.Braun Medical, Inc. DQX Class II 1997-12-19
K973727 ELECTRODE, ELECTROCARDIOGRAPH Don Tay Industries DRX Class II 1997-12-19
K973659 VASOCOR PVR 100 Vasocor, Inc. JOM Class II 1997-12-17
K970367 THERMO-STAT SYSTEM Aquarius Medical Corp. DWJ Class II 1997-12-17
K974175 HEARTPORT ENDOAORTIC CLAMP CATHETER Heartport, Inc. DWZ Class II 1997-12-16
K973818 T-REX BIOPSY FORCEPS Boston Scientific Corp DWZ Class II 1997-12-16
K973494 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG Guidant Corp. DQX Class II 1997-12-12
K971688 IVT 0.014 PTFE-COATED TRACKWIRE Boston Scientific /International Technologies DQX Class II 1997-12-11
K964663 FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX Rmds, Inc. DXC Class II 1997-12-11
K972744 COURIER ST BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1997-12-11
K965158 HEART PROTECTOR (VER 1996) N.P.N.T., Inc. DRT Class II 1997-12-09
K963518 COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. DTZ Class II 1997-12-08
K973472 3M CDI H/S CUVETTES WITH HEPARON TREATMENT 3M Healthcare DRY Class II 1997-12-08
K963982 ACIST ANGIOGRAPHIC INJECTOR Invasatec DXT Class II 1997-12-05
K972649 CARDIOCALL CARDIAC EVENT RECORDER Reynolds Medical , Ltd. DXH Class II 1997-12-04
K971650 RHYTHMSTAT XL Data Critical Corp. DXH Class II 1997-12-04
K973437 HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES Hewlett-Packard GmbH DPS Class II 1997-12-03
K971554 BODYSTAT Bodystat , Ltd. MNW Class II 1997-11-26
K973216 FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) Rmds, Inc. DXC Class II 1997-11-25
K973230 MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) Merit Medical Systems, Inc. DXT Class II 1997-11-25
K973178 FLUORO-TEX SURGICAL MEMBRANE Bridger Biomed, Inc. DXZ Class II 1997-11-24
K973371 CERTODYN RAECG UNIVERSAL ADAPTER B.Braun Medical, Inc. DQY Class II 1997-11-24
K973475 CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) Medtronic Vascular DTR Class II 1997-11-20
K973645 RENEGADE FIBER BRAIDED MICROCATHETER Boston Scientific Corp KRA Class II 1997-11-19
K972357 BLUE MAX - 20 BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1997-11-19
K972623 LMI IRRIGATION CATHETER (IGR) Lucas Medical, Inc. DXE Class II 1997-11-19
K955829 SAFPACE SYSTEM B.Braun Medical, Inc. LDF Class II 1997-11-18
K973401 TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) Cordis Corp. DQO Class II 1997-11-18
K970938 HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING Biocompatibles Cardiovascular, Inc. DQX Class II 1997-11-17
K973147 NPB-295 PULSE OXIMETER Nellcor Puritan Bennett, Inc. DQA Class II 1997-11-14
K963756 IBC CARDIAC SUCTION WARD International Biophysics Corp. DTS Class II 1997-11-14
K971868 IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM Marquette Electronics, Inc. MSX Class II 1997-11-13
K973141 HEART ACCESS PLUS CARDIAC EVENT RECORDER Paceart, Inc. DXH Class II 1997-11-12
K970801 BCI MODEL 6004 NIBP MONITOR (6004) Bci Intl., Inc. DXN Class II 1997-11-12
K972121 ACUITY CENTRAL STATION Protocol Systems, Inc. MLD Class II 1997-11-07

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