meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2004-03-19

Clearances · page 87 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033998 MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V Masimo Corp. DQA Class II 2004-03-19
K040229 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 A&D Engineering, Inc. DXN Class II 2004-03-19
K040481 SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 Intra Luminal Therapeutics, Inc. DQY Class II 2004-03-18
K040162 CORRESTORE PATCH SYSTEM Somanetics Corp. DXZ Class II 2004-03-16
K040298 ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS Acist Medical Systems, Inc. DXT Class II 2004-03-15
K040286 ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS Ethox Corp. DXQ Class II 2004-03-15
K040355 VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING Gish Biomedical, Inc. DTR Class II 2004-03-15
K033894 PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032 Matsushita Electric Works, Ltd. DXN Class II 2004-03-11
K033913 PROGREAT Terumo Medical Corp. KRA Class II 2004-03-11
K033876 DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 Dolphin Medical, Inc. DQA Class II 2004-03-11
K040453 AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 Revivant Corp. DRM Class II 2004-03-11
K034046 RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 Rnk Products DQD Class II 2004-03-10
K040086 HEALTH BUDDY WITH BUDDYLINK Health Hero Network, Inc. DXN Class II 2004-03-10
K040001 STEERABLE STYLET Synovis Surgical Innovations DRB Class II 2004-03-09
K033807 INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER Draeger Medical Systems, Inc. DRQ Class II 2004-03-09
K033410 TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 Remote Diagnostic Technologies , Ltd. DXH Class II 2004-03-05
K040037 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. DQX Class II 2004-03-03
K040357 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II Philips Medical Systems, Inc. MHX Class II 2004-03-03
K040210 CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR Terumo Corp. DTZ Class II 2004-03-03
K031903 RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 Guidant Corporation DTZ Class II 2004-03-03
K032733 PM-8000 PATIENT MONITOR, MODEL 8000 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DRT Class II 2004-03-03
K040345 MODIFICATION TO NITREX NITINOL GUIDEWIRE Ev3, Inc. DQX Class II 2004-03-02
K033881 MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE Medrad, Inc. DXT Class II 2004-03-02
K040023 CAPIOX FLEXIBLE VENOUS RESERVOIR Terumo Cardiovascular Systems Corp. DTN Class II 2004-03-01
K032610 MODIFIED SONAMET BODY COMPOSITION ANALYZER Life Measurement, Inc. OAC Class II 2004-03-01
K033378 VITAL SIGNS MONITOR, PROPAQ LT Welch Allyn Protocol, Inc. MWI Class II 2004-03-01
K040304 PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 Philips Medizin Systeme Boeblingen GmbH MHX Class II 2004-03-01
K033617 EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY Vasomedical, Inc. DRN Class II 2004-03-01
K040100 ARROW ECHOGENIC INTRODUCER NEEDLE Arrow Intl., Inc. DQX Class II 2004-03-01
K040207 EP-4 CLINICAL STIMULATOR Ep Medsystems JOQ Class II 2004-02-27
K032421 AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE Ambu, Inc. MKJ Class III 2004-02-27
K033771 BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR Bio-Detek, Inc. MKJ Class III 2004-02-27
K040032 CENTRAL STATION, VERSION 3.3H Hommed, LLC DXN Class II 2004-02-27
K030722 ENVOY PATIENT MONITOR Mennen Medical, Inc. MHX Class II 2004-02-26
K040252 CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT Rex Medical MCW Class II 2004-02-26
K040184 DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER Cobe Cardiovascular, Inc. DTM Class II 2004-02-26
K040214 MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2004-02-25
K033988 GOLDWAY UT4000A VITAL SIGNS MONITOR Goldway (Us), Inc. MWI Class II 2004-02-25
K040309 DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2004-02-24
K033650 ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER Siemens Medical Solutions USA, Inc. OBJ Class II 2004-02-24
K032888 CREATION NM DIAGNOSTIC CATHETERS Neich Medical (Shenzhen) Company Limited DQO Class II 2004-02-24
K040249 SKINTACT ECG ELECTRODE Leonhard Lang GmbH DRX Class II 2004-02-24
K033030 CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM Witt Biomedical Corp MWI Class II 2004-02-24
K033678 SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 Spectranetics Corp. DQY Class II 2004-02-23
K032979 PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T Philips Medical Systems, Inc. DQA Class II 2004-02-20
K034010 GELSOFT PLUS ERS Vascutek, Ltd. DSY Class II 2004-02-19
K032551 MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR Masimo Corp. DQA Class II 2004-02-19
K033296 MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V Masimo Corp. DQA Class II 2004-02-19
K033633 VASCON POLARIS GUIDING CATHETER Vascon, LLC DQY Class II 2004-02-18
K040139 ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER Endobionics, Inc. KRA Class II 2004-02-18
K040150 MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER Medamicus, Inc. DYB Class II 2004-02-18
K034036 MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 Micro Therapeutics, Inc. KRA Class II 2004-02-13
K033615 WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES Wheaton Franciscan Services Inc., Supply Chain JOW Class II 2004-02-13
K033715 PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER Philips Medical Systems, Inc. DQA Class II 2004-02-13
K040138 VICEROY INFLATION DEVICE Merit Medical Systems, Inc. MAV Class II 2004-02-13
K033270 NOVOSCI READY SYSTEM, MODEL RS-200 Novosci Corp. KFM Class II 2004-02-13
K040243 BARD ATLAS PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. DQY Class II 2004-02-13
K031931 ECHO SOUNDER EX-101EX 8 MHZ Koven Technology, Inc. DPW Class II 2004-02-13
K040140 IQ GUIDE WIRE Boston Scientific Corp DQX Class II 2004-02-12
K032338 TRIO MONITOR MODEL 0998-00-0600 Datascope Corp. MWI Class II 2004-02-11
K032305 OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL Omron Healthcare, Inc. DXN Class II 2004-02-11
K033622 POLARCATH PERIPHERAL DILATATION SYSTEM Cryo Vascular Systems, Inc. DQY Class II 2004-02-10
K033800 CAPIOX CARDIOTOMY RESERVOIR Terumo Cardiovascular Systems Corporation DTN Class II 2004-02-10
K032125 CSTAT, MODELS 09-0014-01 AND 09-0014-02 Vascular Control Systems, Inc. DXC Class II 2004-02-09
K033527 INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER B.Braun Medical, Inc. DYB Class II 2004-02-05
K033451 HEARTRAK SMART AT/HEARTRAK SMART2 Universal Medical, Inc. DXH Class II 2004-02-05
K033997 SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 Bacchus Vascular, Inc. MCW Class II 2004-02-04
K032857 PRESS-MATE BX-10 VITAL SIGN MONITOR Colin Medical Instruments Corp. DXN Class II 2004-02-04
K020983 JOSTRA SUCKERS, MODEL JS Jostra AG DWF Class II 2004-01-30
K034061 MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH Boston Scientific Corp DYB Class II 2004-01-30
K034058 SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 Medtronic Vascular DWF Class II 2004-01-29
K032882 RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 Recom Managed Systems, Inc. MWJ Class II 2004-01-28
K033349 AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 Masimo Corp. DQA Class II 2004-01-28
K031167 HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX Idt Technology Limited MNW Class II 2004-01-28
K023713 SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 Sontra Medical, Inc. KRC Class II 2004-01-28
K033989 MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 Medtronic Inc. Cardiac Rhythm Management DQY Class II 2004-01-22
K033328 NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT Novosci Corp. DTL Class II 2004-01-16
K033726 PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER Precision Vascular KRA Class II 2004-01-16
K033964 SOLAR 9500 INFORMATION MONITOR Ge Medical Systems Information Technologies MHX Class II 2004-01-15
K033513 EASI ECG ALGORITHM Philips Medical Systems DRW Class II 2004-01-15
K033569 FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH Flowmedica, Inc. KRA Class II 2004-01-13
K033323 D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING Dideco S.P.A. DTZ Class II 2004-01-13
K033929 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. DQX Class II 2004-01-12
K033742 BOSTON SCIENTIFIC V-18 CONTROL WIRE Boston Scientific Corp DQX Class II 2004-01-12
K032051 BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P Access Battery, Inc. MKJ Class III 2004-01-09
K033987 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS Dideco S.P.A. DTM Class II 2004-01-08
K033535 LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES Lumend, Inc. PDU Class II 2004-01-07
K032031 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. DQX Class II 2004-01-07
K032763 VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER Vascular Solutions, Inc. QEZ Class II 2003-12-19
K033758 HYDROPHILIC GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2003-12-19
K033657 MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V Living Data Technologies Corporation DRN Class II 2003-12-19
K033159 LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 LeMaitre Vascular, Inc. MJN Class II 2003-12-19
K033672 MODIFICATION TO UNITY NETWORK ID Ge Medical Systems Information Technologies MWI Class II 2003-12-18
K033793 CLEANER II ROTATIONAL THROMBECTOMY SYSTEM Rex Medical MCW Class II 2003-12-16
K032920 THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 Coeur Medical DXT Class II 2003-12-16
K033583 PROGREAT Terumo Medical Corp. DQO Class II 2003-12-12
K031812 TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 Vascular Control Systems, Inc. DXC Class II 2003-12-12
K033298 SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS Masimo Corp. DQA Class II 2003-12-12
K033680 M2376A PHILIPS DEVICE LINK SYSTEM Philips Medical Systems MWI Class II 2003-12-11
K033424 ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 Transonic Systems, Inc. DPW Class II 2003-12-11

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