meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2007-05-11

Clearances · page 75 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063638 MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 St Jude Medical DQY Class II 2007-05-11
K071073 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE Ge Medical Systems Information Technologies MHX Class II 2007-05-11
K062724 ACCUPULSE PULSE OXIMETER Eagle Medical Equipment Co. DQA Class II 2007-05-11
K070086 SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR Sensacare , Ltd. DXN Class II 2007-05-10
K071008 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM Radiant Medical NCX Class II 2007-05-09
K063690 COLIN PRESS MATE, MODEL BP S510 Omron Healthcare, Inc. MHX Class II 2007-05-09
K063752 LIFESENSE, MODEL LS1-9R Nonin Medical, Inc. DQA Class II 2007-05-04
K070240 CARTO XP EP NAVIGATION SYSTEM, VERSION 9 Biosense Webster, Inc. DQK Class II 2007-05-04
K070614 CORSCREEN Viasys Healthcare GmbH DPS Class II 2007-05-04
K070324 IPC-BOOT C-Boot , Ltd. JOW Class II 2007-05-03
K070193 ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES Envitec-Wismar GmbH DQA Class II 2007-05-02
K052480 HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH Hansen Medical, Inc. DXX Class II 2007-05-02
K070750 247 BP DEVICE Suntech Medical, Inc. DXN Class II 2007-05-02
K070902 MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 St Jude Medical DQK Class II 2007-05-01
K063137 PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 Pharmasmart, Inc. DXN Class II 2007-05-01
K063783 PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A Philips Medical Systems, Inc. DQA Class II 2007-04-27
K070410 COOK MICROWIRE WIRE GUIDE Cook, Inc. DQX Class II 2007-04-27
K063695 RUNTHROUGH NS Terumo Medical Corp. DQX Class II 2007-04-27
K071011 MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER Braemar, Inc. MWJ Class II 2007-04-27
K063503 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION Mallinckrodt Inc., Liebel-Flarsheim Business IZQ Class II 2007-04-27
K070455 ZOLL E SERIES WITH SEE-THRU CPR Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2007-04-26
K070839 MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR Terumo Cardiovascular Systems Corp. DTN Class II 2007-04-24
K070521 MODIFIED MERCY RETRIEVER, MODEL 90070 Concentric Medical, Inc. NRY Class II 2007-04-24
K061815 COOK CELECT VENA CAVA FILTER William Cook Europe Aps DTK Class II 2007-04-20
K070710 ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM Biosensors International-USA DRS Class II 2007-04-19
K070254 HORIZON SE Mennen Medical , Ltd. DQK Class II 2007-04-19
K063784 DYE MANAGEMENT SYSTEM Icu Medical, Inc. DQO Class II 2007-04-16
K070136 AUDICOR 200 SYSTEM, MODELS 200D AND 200S Inovise Medical, Inc. DPS Class II 2007-04-13
K062449 EMPOWERMR INJECTOR SYSTEM, MODEL 9730 E-Z-Em, Inc. IZQ Class II 2007-04-13
K061896 MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N Mediaid, Inc. DQA Class II 2007-04-12
K070706 EP-WORKMATE Ep Medsystems DQK Class II 2007-04-11
K062194 HYPERVISOR VI CENTRAL MONITORING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2007-04-11
K070818 MEDILOGAR4, MEDILOGAR12 Tom Medical Entwicklungs GmbH DSH Class II 2007-04-06
K070624 HYPERQ SYSTEM Biological Signal Processing, Ltd. MWI Class II 2007-04-06
K070166 STRADA CAROTID GUIDING SHEATH St Jude Medical DYB Class II 2007-04-06
K070051 ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM Acumen Medical, Inc. DQY Class II 2007-04-06
K070680 CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 Cardiomems, Inc. NQH Class II 2007-04-05
K050415 IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS Impedimed Pty , Ltd. OBH Class II 2007-03-30
K070384 ARGON CONTINUOUS FLUSH DEVICE Argon Medical Devices, Inc. KRA Class II 2007-03-29
K063076 REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER Ascent Healthcare Solutions OWQ Class II 2007-03-29
K070423 TR BAND Terumo Medical Corp. DXC Class II 2007-03-28
K070543 MODIFICATION TO HEALTH BUDDY APPLIANCE Health Hero Network, Inc. DRG Class II 2007-03-28
K063090 MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY Medrad, Inc. IZQ Class II 2007-03-27
K070232 ECG CABLES, TRUNK AND PATIENT LEAD WIRES American I.V. Products, Inc. DSA Class II 2007-03-27
K060976 MOORLD12-B1 LASER DOPPLER BURNS IMAGER Moor Instruments, Ltd. DPT Class II 2007-03-27
K063044 CARDIOBELT ELECTRODE BELT Monebo Technologies, Inc. DRX Class II 2007-03-23
K062033 BP 101 DIGITAL BLOOD PRESSURE MONITOR Kingyield Hongkong Limited DXN Class II 2007-03-23
K070204 LINK TO ACUITY CLINICIAN NOTIFIER Welch Allyn Protocol, Inc. MSX Class II 2007-03-23
K062282 MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 Monebo Technologies, Inc. DPS Class II 2007-03-22
K070485 BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L Cardiva Medical, Inc. DXC Class II 2007-03-22
K070213 PERFORMER CBP SYSTEM Rand S.R.L. DTQ Class II 2007-03-21
K070588 PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) Philips Medical Systems MHX Class II 2007-03-20
K070011 IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER Irvine Biomedical,Inc.(Ibi) DQO Class II 2007-03-20
K063863 ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER Advantage Medical Cables, Inc. DXQ Class II 2007-03-20
K070487 SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX Volcano Corporation DXO Class II 2007-03-16
K062976 MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER Ge Medical Systems Information Technologies DSI Class II 2007-03-16
K070539 MORTARA ELI 10 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2007-03-15
K063490 SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 Spacelabs Medical, Inc. DQK Class II 2007-03-15
K070448 CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 Cardiomems, Inc. NQH Class II 2007-03-15
K063210 ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 Medtronic Inc. Cardiac Rhythm Management DQX Class II 2007-03-15
K063844 REPROCESSED HEART STABILIZERS AND POSITIONERS Sterilmed, Inc. NQG Class I 2007-03-15
K070279 MODIFICATION TO HYPERTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 2007-03-14
K070421 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 GE Healthcare MSX Class II 2007-03-13
K063618 TENDERFLOW PERIATRIC ARTERIAL CANNULA Terumo Cardiovascular Systems Corp. DWF Class II 2007-03-13
K063563 CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER Cordis Europa, N.V. LIT Class II 2007-03-07
K063814 BP-200 PLUS Schiller AG DXN Class II 2007-03-07
K061706 CADWELL EASYNET OXIMETER MODULE Cadwell Laboratories, Inc. DQA Class II 2007-03-05
K063871 D-STAT HANDLE, MODEL 8500-053 Vascular Solutions, Inc. DXC Class II 2007-02-28
K062977 CRITIVIEW, MODEL CRV3 Critisense , Ltd. DPW Class II 2007-02-28
K062537 ZOLL M SERIES WITH REAL CPR HELP ZOLL Medical Corporation MKJ Class III 2007-02-28
K070238 AMPLATZER RELIANT CATHETER DELIVERY SYSTEM Aga Medical Corp. DQY Class II 2007-02-28
K070197 ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY Acumen Medical, Inc. DYB Class II 2007-02-23
K070260 STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0 Philips Medical Systems DSI Class II 2007-02-23
K070280 CARDIODAY, VERSION 2.0 Getemed Medizin- Und Informationstechnik AG DQK Class II 2007-02-23
K062852 BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 Onset Medical Corporation DYB Class II 2007-02-23
K063349 CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR Cormatrix Cardiovascular, Inc. DXZ Class II 2007-02-16
K061379 INFINITY TELESMART TELEMETRY SYSTEM Draeger Medical Systems, Inc. MHX Class II 2007-02-16
K070150 VASCUPUNCTURE PICC GUIDEWIRE Neometrics, Inc. DQX Class II 2007-02-15
K062603 BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 Biospace Corporation Limited MNW Class II 2007-02-15
K070323 TEMPORARY LIMB SALVAGE SHUNT Vascutek, Ltd. DXC Class II 2007-02-15
K070161 QUATTRO CATHETER MODEL IC4593 Alsius Corp. NCX Class II 2007-02-15
K062569 SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING Datascope Corp. DXC Class II 2007-02-14
K062894 INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 Dailycare Biomedical, Inc. DPS Class II 2007-02-08
K063725 MP5 INTELLIVUE PATIENT MONITOR Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2007-02-08
K062554 STARCLOSE HEX-HUB DILATOR Abbott Vascular, Inc. DRE Class II 2007-02-06
K063840 XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION Witt Biomedical Corp MWI Class II 2007-02-06
K062893 KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A Shanghai Kodea Economic and Trade Development , Ltd. DXN Class II 2007-02-05
K062098 SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX Datascope Corp. MHX Class II 2007-02-05
K063111 FINOMETER MODEL-2 WITH ACCESSORIES Finapres Medical Systems B.V. DXN Class II 2007-02-01
K061931 SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 Solaris Medical Technology, Inc. DQA Class II 2007-01-31
K063819 ASAHI PTCA GUIDE WIRE, FIELDER FC Asahi Intecc Co., Ltd. DQX Class II 2007-01-26
K063510 LIFEPAK 12 DEFIBRILLATOR/MONITOR Medtronic Emergency Response Systems, Inc. MKJ Class III 2007-01-26
K062099 PHASE 3, MODEL DT-1 Datrend Systems, Inc. DRL Class II 2007-01-25
K063586 MOORFLPI FULL-FIELD LASER PERFUSION IMAGER Moor Instruments, Ltd. DPT Class II 2007-01-25
K062397 SENTINEL Del Mar Reynolds Medical, Ltd. DXH Class II 2007-01-25
K063774 MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 Concentric Medical, Inc. NRY Class II 2007-01-24
K063434 TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM Radiometer Basel AG DQA Class II 2007-01-22
K063829 THERMOGARD THERMAL REGULATION SYSTEM Alsius Corp. NCX Class II 2007-01-22
K061670 LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE William Cook Europe Aps DQX Class II 2007-01-19
K062046 MODIFIED MERCI RETRIEVER, MODEL 90050 Concentric Medical, Inc. NRY Class II 2007-01-19

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