meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
2005-06-29

Clearances · page 82 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051471 CARDIODAY Getemed Medizin- Und Informationstechnik AG DQK Class II 2005-06-29
K051395 LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER Vascular Solutions, Inc. DQO Class II 2005-06-24
K050877 CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR Biosense Webster, Inc. DRF Class II 2005-06-24
K051475 ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL Medical Corporation MKJ Class III 2005-06-24
K051546 BPCALIBRATOR MC3000/MC3100 Healthstats International Pte. , Ltd. DXN Class II 2005-06-24
K050844 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL Cas Medical Systems, Inc. DQA Class II 2005-06-23
K051374 CARDIODRIVE CATHETER ADVANCEMENT SYSTEM Stereotaxis, Inc. DQX Class II 2005-06-23
K051283 MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE Cardiopulmonary Corp. MSX Class II 2005-06-23
K051254 PERIPHERAL CUTTING BALLOON Boston Scientific Ivt PNO Class II 2005-06-22
K050056 MODEL 2500A PALMSAT PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2005-06-21
K051519 FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) Abbott Laboratories (Perclose, Inc.) LIT Class II 2005-06-21
K050995 REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER Volcano Corporation OBJ Class II 2005-06-20
K051021 ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A Shanghai Lord International Trade Co., Ltd. DXQ Class II 2005-06-20
K051367 PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 Ge Medical Systems Information Technologies MHX Class II 2005-06-20
K050456 MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Medrad, Inc. DXT Class II 2005-06-17
K051319 LYSUS INFUSION SYSTEM Ekos Corp. QEY Class II 2005-06-15
K050919 LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P Analogic Corp. DSI Class II 2005-06-14
K051220 REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. NLH Class II 2005-06-14
K050964 PV 1900 SYNCHRO 0.016 GUIDEWIRE Boston Scientific - Precision Vascular DQX Class II 2005-06-13
K051084 DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE Denver Biomedicals, Inc. DWM Class II 2005-06-13
K051303 BIO-CONSOLE, MODEL 560 Medtronic Perfusion Systems DWA Class II 2005-06-10
K051228 BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG Cardiodynamics International Corp. DSB Class II 2005-06-10
K051225 EKOS MICRO-INFUSION SYSTEM Ekos Corp. NUI Class II 2005-06-10
K050916 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] Intra Luminal Therapeutics, Inc. PDU Class II 2005-06-08
K051470 REMOTE CARE MANAGEMENT SYSTEMS (RCMS) Bl Healthcare, Inc. DRG Class II 2005-06-08
K051179 EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 Boston Scientific Corp NFA Class II 2005-06-08
K050371 MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER Medrad, Inc. DQO Class II 2005-06-07
K050915 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] Intra Luminal Therapeutics, Inc. DQX Class II 2005-06-07
K051043 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2005-06-06
K050599 TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER Boston Scientific Corp DQY Class II 2005-06-03
K050763 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2005-06-01
K051107 ONYX II FINGER PULSE OXIMETER, MODEL 9550 Nonin Medical, Inc. DQA Class II 2005-06-01
K051067 PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) LeMaitre Vascular, Inc. MJN Class II 2005-05-27
K050146 VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY Vascular Solutions, Inc. DXC Class II 2005-05-27
K050006 BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO C.R. Bard, Inc. DRQ Class II 2005-05-27
K050873 CANALIZER HYDROPHILIC GUIDE WIRE Medical Device Technologies, Inc. DQX Class II 2005-05-26
K051060 ANGIODYNAMICS PROFILER PTA BALLOON CATHETER AngioDynamics, Inc. DQY Class II 2005-05-26
K050248 ELECTRODE Electramold DRX Class II 2005-05-25
K050389 ULTRA-SOFT SV BALLOON DILATATION CATHETER Boston Scientific Corp DQY Class II 2005-05-25
K050684 ATLANTIS PV Boston Scientific Corp DQO Class II 2005-05-20
K051232 D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER Dideco S.R.L. DTM Class II 2005-05-20
K050929 THE HERMES SYSTEM Palaistra Systems, Inc. DRG Class II 2005-05-20
K050731 SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM Ge Medical Systems Information Technologies MWJ Class II 2005-05-19
K050884 ADAPTER CABLE Remington Medical, Inc. DTA Class II 2005-05-19
K043489 ENPATH DEFLECTABLE CATHETER Enpath Medical Incorporated DQY Class II 2005-05-19
K051126 CARDIOSCOPE SONOPLUS 3000 Pulsonic Ag, Medical Technology DPS Class II 2005-05-19
K050168 LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER Vascular Solutions, Inc. DQO Class II 2005-05-18
K051096 APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 St. Jude Medical, Daig Division, Inc. DYB Class II 2005-05-17
K051076 ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES ZOLL Medical Corporation MKJ Class III 2005-05-13
K050093 MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM Ge Medical Systems Information Technologies DQK Class II 2005-05-13
K050128 VITALWARE VMS Televital, Inc. DRG Class II 2005-05-13
K050680 BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 OSTAR MEDITECH CORP. DXN Class II 2005-05-13
K050130 KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM Kerberos Proximal Solutions, Inc. QEZ Class II 2005-05-13
K050252 AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS Masimo Corporation DQA Class II 2005-05-11
K050926 TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 Idev Technologies, Inc. MMX Class II 2005-05-09
K050470 CONCENTRIC EMBOLIC PEARLS Concentric Medical, Inc. KRD Class II 2005-05-06
K050962 MERIT PRELUDE SHEATH INTRODUCER Merit Medical Systems, Inc. DRE Class II 2005-05-06
K050890 ECC.O SYSTEM Dideco S.R.L. KFM Class II 2005-05-05
K043509 GUNTHER TULIP VENA CAVA FILTER SET Cook, Inc. DTK Class II 2005-05-05
K050756 SKIPPER AND SKIPPER RACE GUIDEWIRE Invatec Innovative Technologies, S.R.L. DQX Class II 2005-05-05
K050561 WINDSURFER Medcon , Ltd. DQK Class II 2005-05-04
K050686 CARDIOVIT AT-10PLUS Schiller AG DPS Class II 2005-05-04
K050605 SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 Spacelabs Medical, Inc. DSI Class II 2005-05-03
K043084 PREMERE DELIVERY SHEATH, MODEL PDS Velocimed, Inc. DYB Class II 2005-05-02
K050974 DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS Draeger Medical Systems, Inc. DRQ Class II 2005-04-29
K043604 LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE Vivometrics, Inc. DQK Class II 2005-04-29
K050794 ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER Possis Medical, Inc. QEZ Class II 2005-04-28
K041826 EKOS ULTRASOUND INFUSION SYSTEM Ekos Corp. NUI Class II 2005-04-27
K043380 MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 Monebo Technologies, Inc. DPS Class II 2005-04-26
K050762 PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 Philips Medizin Systeme Boeblingen GmbH MHX Class II 2005-04-22
K043531 MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 K-Jump Health Co., Ltd. DXN Class II 2005-04-21
K043538 HYPERTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 2005-04-18
K042449 DOLPHIN INFLATION DEVICE Sedat S.A. MAV Class II 2005-04-18
K050601 SMARTDOP 45 VASCULAR DOPPLER Koven Technology, Inc. DPW Class II 2005-04-15
K050038 RELIANT STENT GRAFT BALLOON CATHETER Medtronic Endovascular Innovations DQY Class II 2005-04-13
K050778 TELEREHAD 2004 Scottcare DRG Class II 2005-04-13
K050083 BLOOD-PRESSURE METER, BPW120 Idt Technology Limited DXN Class II 2005-04-08
K050225 HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM Cambridge Heart, Inc. DQK Class II 2005-04-07
K050711 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT Health & Life Co., Ltd. DXN Class II 2005-04-07
K042007 ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corp MKJ Class III 2005-04-07
K050714 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS Health & Life Co., Ltd. DXN Class II 2005-04-07
K042505 OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N Omron Healthcare, Inc. DXN Class II 2005-04-05
K050614 MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies DQK Class II 2005-04-05
K042506 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M Omron Healthcare, Inc. DXN Class II 2005-04-05
K050742 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 Philips Medical Systems MHX Class II 2005-04-05
K050169 HL 200 ELECTRONIC STETHOSCOPE Health & Life Co., Ltd. DQD Class II 2005-04-05
K050567 HEALTH BUDDY APPLIANCE Health Hero Network, Inc. DRG Class II 2005-04-05
K050587 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM Health & Life Co., Ltd. DXN Class II 2005-04-05
K050645 CORDIS AMIIA .014 PTA BALLOON CATHETER Cordis Corp. LIT Class II 2005-04-01
K050491 H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF Health & Life Co., Ltd. DXN Class II 2005-03-31
K050172 CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 Cardiomedics, Inc. DRN Class II 2005-03-31
K043352 GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR Gocanning Technology , Ltd. DXN Class II 2005-03-31
K050577 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 Boston Scientific Corp DQO Class II 2005-03-30
K050217 FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) Biosense Webster, Inc. MTD Class II 2005-03-30
K050249 HL168JP Health & Life Co., Ltd. DXN Class II 2005-03-30
K050040 MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR Mars Medical Products DXN Class II 2005-03-30
K050670 SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS Tms Telemedizinische Systeme GmbH DXH Class II 2005-03-30
K050563 EKOS PERIPHERAL INFUSION SYSTEM Ekos Corp. QEY Class II 2005-03-29
K043392 REPROCESSED ELECTROPHYSIOLOGY CATHETERS Alliance Medical Corp. NLH Class II 2005-03-25
K050697 MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2005-03-25

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