meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
2011-01-25

Clearances · page 60 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K103166 CHEETAH RELIANT Cheetah Medical, Inc. DSB Class II 2011-01-25
K101604 VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V Vascular Solutions, Inc. DYB Class II 2011-01-24
K103746 CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) Biosense Webster, Inc. DQK Class II 2011-01-21
K101354 FETCH 2 ASPIRATION CATHETER MODEL 109400-001 Medrad Interventional/Possis QEZ Class II 2011-01-21
K103468 STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) Sorin Group Deutschland GmbH DWA Class II 2011-01-20
K103762 SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE Sorin Group Deutschland GmbH DTQ Class II 2011-01-20
K102893 PCP/PC STETHOSCOPE Rnk Products, Inc. DQD Class II 2011-01-20
K103715 COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE Mirador Biomedical, Inc. DRS Class II 2011-01-20
K102940 VASCOPRESS SEQUENTIAL DVT PUMP Compression Therapy Concepts JOW Class II 2011-01-20
K100585 MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 Gaymar Industries, Inc. DWJ Class II 2011-01-20
K103250 CPS DIRECT SL II SLITTABLE OUTER CATHETER St. Jude Medical, Cardiac Rhythm Management Divisi DQY Class II 2011-01-19
K103080 ALBOGRAFT VASCULAR PROSTHESIS LeMaitre Vascular, Inc. MAL Class II 2011-01-19
K101599 RVT CTO DEVICE Revascular Therapeutics, Inc. PDU Class II 2011-01-18
K103469 STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 Sorin Group Deutschland GmbH KRL Class II 2011-01-18
K103334 CARDIO MED Cardio Medical Products, Inc. LDD Class II 2011-01-18
K102979 NEXGEN PERIPHERAL GUIDE CATHETER Nexgen Medical Systems, Inc. DQY Class II 2011-01-18
K103652 SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 Philips Medical Systesms MHX Class II 2011-01-13
K101995 CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD Oridion Capnography, Inc. DQA Class II 2011-01-11
K103159 CARDIO MED MODEL A102, H104, O101, P103, AND Z100 Cardio Medical Products, Inc. LDD Class II 2011-01-11
K103110 MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER Abbott Vascular-Cardiac Therapies LOX Class II 2011-01-10
K103046 HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE Hosman International Co., Ltd. DXN Class II 2011-01-10
K103646 INTELLIVUE MX40 PATIENT MONITOR Phillips Medical Systems MHX Class II 2011-01-07
K102823 DISPOSABLE BLOOD PRESSURE CUFF Wuxi Medical Instrument Factory DXQ Class II 2011-01-07
K103168 B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) Sorin Group Deutschland GmbH DRY Class II 2011-01-06
K101024 KENZ CARDY302 MAX Suzuken Co., Ltd. MWJ Class II 2011-01-06
K103534 GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE Trireme Medical, Inc. DQY Class II 2011-01-05
K103618 TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM Ev3, Inc. MCW Class II 2011-01-05
K102974 INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 Philips Medical Systems MSX Class II 2011-01-04
K103153 VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER Abbott Vascular-Cardiac Therapies LOX Class II 2010-12-30
K101450 CANTATA MICROCATHETER Cook, Inc. KRA Class II 2010-12-30
K103357 LIFEBRIDGE Lifebridge Medizintechnik AG KFM Class II 2010-12-27
K102835 VITAL SIGNS MONITOR Edan Instruments, Inc. DQA Class II 2010-12-27
K102595 MEDISTIM VERIQC SYSTEM Medi-Stim Asa DPW Class II 2010-12-27
K094030 FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 Cas Medical Systems, Inc. MUD Class II 2010-12-23
K102350 PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2010-12-22
K103405 PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH Vascular Solutions, Inc. QEZ Class II 2010-12-22
K101189 REAVILLMED PRESSURE MONITORING SYSTEM AND PICC Reavillmed DRS Class II 2010-12-22
K103464 PACIFIC XTREME PTCA BALLOON DILATATION CATHETER Medtronic, Inc. LIT Class II 2010-12-22
K102972 LIFEPAK 12 Physio-Control, Inc. MKJ Class III 2010-12-22
K101982 MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 St Jude Medical, Crmd DTA Class II 2010-12-21
K102715 REGIONAL OXIMETER Nonin Medical, Inc. MUD Class II 2010-12-17
K102106 NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION Nihon Kohden Corp. DRG Class II 2010-12-17
K103432 UNITY NETWORK ID Ge Medical Systems Information Technologies, Inc. MWI Class II 2010-12-17
K101659 SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 Vascular Solutions, Inc. DQY Class II 2010-12-16
K100646 AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE Medtronic, Inc. DTM Class II 2010-12-16
K102624 AVITA WRIST TYPE BLOOD PRESSURE MONITOR Avita Corporation DXN Class II 2010-12-16
K101012 V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 Taidoc Technology Corporation DQA Class II 2010-12-15
K103459 VASCUTRAK PTA DILATATION CATHETER C.R. Bard, Inc. PNO Class II 2010-12-13
K103247 VASCUCOMP Thermotek, Inc. JOW Class II 2010-12-10
K102645 WILLOW/ELM PTA BALLOON DILATATION CATHETER Creagh Medical, Ltd. LIT Class II 2010-12-10
K102473 MULLINS-X PTV CATHETER NuMED, Inc. OMZ Class II 2010-12-09
K102723 MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS Memtec Corp. MWJ Class II 2010-12-09
K102609 KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Medical Co., Ltd. DXN Class II 2010-12-09
K101046 STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM Sorin Group Deutschland GmbH DTX Class II 2010-12-09
K103356 PRUITT CAROTID KIT LeMaitre Vascular, Inc. MJN Class II 2010-12-08
K103367 SEEKER CROSSING SUPPORT CATHETER Bard Peripheral Vascular, Inc. DQY Class II 2010-12-08
K101153 QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD Maquet Cardiopulmonary, AG DTZ Class II 2010-12-08
K102422 SPACELABS MEDICAL PATIENT MONITORS Spacelabs Medical, Inc. MHX Class II 2010-12-07
K100739 VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 Edwards Lifesciences, LLC KRB Class II 2010-12-07
K102705 ARMADA 14 PTA CATHETER Abbott Vascular, Inc. LIT Class II 2010-12-07
K100709 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M Edwards Lifesciences, LLC DXG Class II 2010-12-07
K102376 NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 Nihon Kohden Corp. MHX Class II 2010-12-07
K102111 MEDICAL MAGNETIC TAPE RECORDER Wpr Medical AS DSI Class II 2010-12-07
K103322 EVERCROSS 0.035 OTW PTA DILATION CATHETER Ev3, Inc. LIT Class II 2010-12-06
K103283 PHYSIOFLOW ENDURO Vasocom, Inc. DSB Class II 2010-12-03
K100040 BIOHARNESS Zephyr Technology Corporation MHX Class II 2010-12-03
K102818 MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE Micrus Endovascular Corporation DQX Class II 2010-12-03
K102854 PC ECG Edan Instruments, Inc. DPS Class II 2010-12-03
K102579 HYPERQ AD-100 SYSTEM Biological Signal Processing, Ltd. MWI Class II 2010-12-02
K102830 ELECTROCARDIOGRAPH Edan Instruments, Inc. DPS Class II 2010-12-02
K101577 MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2010-12-02
K103214 M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 Lifeline Systems, Inc. DRG Class II 2010-12-01
K102035 SLEEK OTW PTA CATHETERS ClearStream Technologies , Ltd. LIT Class II 2010-12-01
K101784 MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX Great Batch Medical DYB Class II 2010-11-26
K101539 VITAL SIGNS MONITOR MODEL M3B Edan Instruments, Inc. DQA Class II 2010-11-24
K102690 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2010-11-24
K103268 OMNI EXPRESS Infinium Medical MWI Class II 2010-11-23
K103057 ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE Asahi Intecc Co., Ltd. DQX Class II 2010-11-19
K102147 CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 Cardioquip Llp DWC Class II 2010-11-19
K102433 MOORVMS-PRES PRESSURE CUFF CONTROLLER Moor Instruments, Ltd. DPW Class II 2010-11-18
K101031 MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 Masimo Corporation DQA Class II 2010-11-18
K102112 CRITICOOL PRO Mtre Advanced Technology , Ltd. DWJ Class II 2010-11-18
K102365 MICROPLEX COIL SYSTEM- COSMOS MicroVention, Inc. KRD Class II 2010-11-18
K102657 CONCENTRIC BALLOON GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2010-11-17
K102540 PTFE PORTABLE INTRODUCER Great Batch Medical DYB Class II 2010-11-16
K100565 DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 Bio-Detek, Inc. MKJ Class III 2010-11-16
K102068 MINIATURIZE CHEST COMPRESSOR (MCC) Resuscitation International DRM Class II 2010-11-16
K101619 WELCH ALLYN 1500 PATIENT MONITOR Schiller AG MHX Class II 2010-11-12
K102048 ATRAUMATIC VASCULAR CLAMPS Geomed Medizin-Technik GmbH & Co. KG DXC Class II 2010-11-09
K102988 ELECTRONIC BLOOD PRESURE MONITOR Shenzhen Pango Electronic Co., Ltd. DXN Class II 2010-11-09
K102484 SEQURE SNARE SYSTEM Lifetech Scientific (Shenzhen) Co., Ltd. MMX Class II 2010-11-09
K102757 LIFENET SYSTEM Physio-Control, Inc. MSX Class II 2010-11-05
K102631 KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2010-11-04
K102930 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2010-11-03
K102905 GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) Mediguide, Ltd. DQK Class II 2010-10-29
K101035 WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 Wmi Enterprises, LLC JOW Class II 2010-10-29
K102906 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2010-10-29
K092896 REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS Nemoto Kyorindo Co., Ltd. DXT Class II 2010-10-29
K101123 NEXFIN MODEL 2 Bmeye B.V. DXN Class II 2010-10-28
K101571 XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS Witt Biomedical Corp MWI Class II 2010-10-26

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