meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
2006-10-06

Clearances · page 77 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K062609 MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER AngioDynamics, Inc. DQY Class II 2006-10-06
K060927 CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES Ceres Medical Systems, LLC DQY Class II 2006-10-06
K062818 FLEXITOUCH SYSTEM Tactile Systems Technology, Inc. JOW Class II 2006-10-06
K061626 VASORING* VRC VASCULAR RING CONNECTOR Sunwei Tech Co. , Ltd. DSY Class II 2006-10-05
K061585 OPTICATH CENTRAL VENOUS OXIMETRY CATHETER Hospira, Inc. DQE Class II 2006-10-05
K061984 TREASURE Asahi Intecc Co., Ltd. DQX Class II 2006-10-05
K062387 SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM Boston Scientific PNO Class II 2006-10-05
K060012 CLIRPATH TURBO PERIPHERAL CATHETERS Spectranetics Corp. PDU Class II 2006-09-29
K052544 PULSE OXIMETER ADAPTER CABLES American I.V. Products, Inc. DQA Class II 2006-09-29
K062576 DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES GE Healthcare MHX Class II 2006-09-29
K062095 MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 Spacelabs Medical, Inc. MHX Class II 2006-09-29
K062462 NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L Jawon Medical Co., Ltd. DXN Class II 2006-09-29
K062304 DLM112 DAYLINK MONITOR Rtx Healthcare A/S DRG Class II 2006-09-29
K062396 MODIFICATION TO STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH DTQ Class II 2006-09-28
K062401 MODIFICATION TO LUCAS Jolife AB DRM Class II 2006-09-28
K061976 CKIS-004A INJECTOR SYNCHRONIZATION OPTION Toshiba America Medical Systems, In.C DXT Class II 2006-09-27
K062429 MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH Edwards Lifesciences Research Medical DTM Class II 2006-09-27
K061967 SCD GARMENT, MODEL VP530 Compression Therapy Concepts, Inc. JOW Class II 2006-09-25
K062342 TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT Sentra Medical Devices, LLC DRS Class II 2006-09-25
K062119 HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 Medical Products Mfg., LLC DRM Class II 2006-09-22
K062531 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE Cordis Corp., A Johnson & Johnson Co. NTE Class II 2006-09-22
K062238 TYTAN BLOOD PRESSURE CUFF Tytan Medical Corp. DXQ Class II 2006-09-21
K062275 RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 Kerberos Proximal Solutions, Inc. QEZ Class II 2006-09-20
K062594 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation DQY Class II 2006-09-20
K062172 FETCH ASPIRATION CATHETER Possis Medical, Inc. QEZ Class II 2006-09-20
K062283 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS Philips Medical Systems North America, Inc. MHX Class II 2006-09-20
K061023 THERMOSUIT SYSTEM Life Recovery Systems Hd, LLC NZE Class II 2006-09-20
K062278 SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 Spacelabs Medical, Inc. MSX Class II 2006-09-19
K061573 TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT Hospira, Inc. DRS Class II 2006-09-19
K061790 PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES Protein Polymer Technologies, Inc. KRD Class II 2006-09-19
K061741 MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM GE Healthcare DQK Class II 2006-09-15
K061502 MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 Medic4all (Israel) , Ltd. DRG Class II 2006-09-15
K061557 FUSION Medwave, Inc. DXN Class II 2006-09-15
K061780 TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + Rozinn Electronics, Inc. DXH Class II 2006-09-15
K061932 BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE Cardiopulmonary Corp. MSX Class II 2006-09-14
K060651 PROXIS SYSTEM, MODEL EPS101 St Jude Medical NFA Class II 2006-09-13
K062468 SPECTRUM M2 MONITOR Spectrum Medical, Llp DRY Class II 2006-09-13
K061471 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC Microlife Intellectual Property GmbH DXN Class II 2006-09-11
K062420 5F SHERPA ACTIVE NX GUIDE CATHETER Medtronic Vascular DQY Class II 2006-09-08
K052523 PROXIS SYSTEM Velocimed, Inc. NFA Class II 2006-09-07
K062392 PHILIPS MP5 INTELLIVUE PATIENT MONITOR Philips Medizin Systeme Boeblingen GmbH MHX Class II 2006-09-06
K061958 MEDTRONIC EXPORT XT CATHETER Medtronic Vascular QEZ Class II 2006-09-05
K061960 FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 Cas Medical Systems, Inc. MUD Class II 2006-09-05
K061442 PULSE OXIMETER, MODEL PM-50 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DQA Class II 2006-09-05
K061075 BOOMERANG WIRE Cardiva Medical, Inc. DXC Class II 2006-09-01
K061045 REPROCESSED ELECTROPHYSIOLOGY CATHETERS Alliance Medical Corp. NLH Class II 2006-08-31
K053556 BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 Jawon Medical Co., Ltd. MNW Class II 2006-08-31
K062088 PREMIER 11 HOLTER Diagnostic Monitoring Software MLO Class II 2006-08-25
K061293 TELAHEART DIGITAL RECORDER North East Monitoring, Inc. MWJ Class II 2006-08-25
K061733 ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER AngioDynamics, Inc. DQO Class II 2006-08-24
K062381 CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR Terumo Cardiovascular Systems Corp. DTZ Class II 2006-08-24
K062145 MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 Acumen Medical, Inc. DYB Class II 2006-08-23
K062134 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR Edwards Lifesciences, LLC DXG Class II 2006-08-22
K061628 JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 Maquet Cardiopulmonary, AG DTZ Class II 2006-08-22
K061866 NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS Thermotek, Inc. JOW Class II 2006-08-22
K060911 CG-6108 ARRHYTHMIA ECG EVENT RECORDER Card Guard Scientific Survival , Ltd. DXH Class II 2006-08-22
K061369 TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 Cardiacassist, Inc. DWA Class II 2006-08-22
K061959 MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 Mytech Technology Co., Ltd. DXN Class II 2006-08-22
K061480 ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM Medtronic, Ireland DQY Class II 2006-08-21
K061279 LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Little Doctor (Shanghai) Electronic DXN Class II 2006-08-18
K062084 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 Acumen Medical, Inc. DQY Class II 2006-08-18
K062168 CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA Nemoto Kyorindo Co., Ltd. DXT Class II 2006-08-18
K060559 ZOLL R SERIES DEFIBRILLATOR ZOLL Medical Corporation MKJ Class III 2006-08-17
K062007 DMS 300-7 Diagnostic Monitoring Software DSH Class II 2006-08-16
K061463 ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S Biosense Webster, Inc. DRF Class II 2006-08-14
K060576 NELLCOR OXIMAX N-600X PULSE OXIMETER Nellcor Puritan Bennett, Inc. DQA Class II 2006-08-14
K061468 REFSTAR EXTERNAL REFERENCE PATCH Biosense Webster, Inc. DRF Class II 2006-08-14
K061760 ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 K-Jump Health Co., Ltd. DXN Class II 2006-08-14
K061610 PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH MHX Class II 2006-08-14
K062201 SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. NFA Class II 2006-08-11
K061707 HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS Philips Medical Systems MKJ Class III 2006-08-11
K062220 MODIFICATION TO GUARDDOG OCCLUSION SYSTEM Possis Medical, Inc. MJN Class II 2006-08-11
K061332 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) Boston Scientific Corp NFA Class II 2006-08-11
K061832 JOSTRA HLM TUBING SETS WITH SAFELINE COATING Maquet Cardiopulmonary, AG DWF Class II 2006-08-11
K061994 WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE GE Healthcare MSX Class II 2006-08-11
K061086 DM-3000 DIGITAL BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2006-08-10
K042850 CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) Stereotaxis, Inc. DQY Class II 2006-08-09
K062126 EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 Biosphere Medical, Inc. DQO Class II 2006-08-09
K061727 GORE PRECLUDE VESSEL GUARD W. L. Gore & Associates, Inc. MFX Class II 2006-08-07
K060307 12 RL ALGORITHM Ge Medical Systems Information Technologies DRT Class II 2006-08-04
K061450 HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS Hospira, Inc. DQE Class II 2006-08-04
K061963 MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 Micrus Endovascular Corporation DQO Class II 2006-08-04
K060010 NAUTIFLUX Sedat DQO Class II 2006-08-04
K061015 FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER St Jude Medical DYB Class II 2006-08-03
K061565 LANGSTON DUAL LUMEN CATHETER Vascular Solutions, Inc. DQO Class II 2006-08-02
K061822 OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 Omron Healthcare, Inc. DXN Class II 2006-08-02
K061675 VISION VXC CENTRAL STATION, MODEL 4300 Invivo Corporation MHX Class II 2006-08-02
K060297 PEPER Medical Monitors, Ltd. DXH Class II 2006-08-02
K061513 LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET Smiths Medical Asd, Inc. DWJ Class II 2006-08-01
K053092 MEDCOMP VASCU-SHEATH II Medcomp DYB Class II 2006-08-01
K060833 12SL ECG ANALYSIS PROGRAM Ge Medical Systems Information Technologies MHX Class II 2006-08-01
K061857 MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR Bio Compression Systems, Inc. JOW Class II 2006-08-01
K061843 VENTURE WIRE CONTROL CATHETER, MODEL WCC St Jude Medical DQY Class II 2006-08-01
K061204 MASIMO SET RADICAL 7 PULSE CO-OXIMETER Masimo Corporation DQA Class II 2006-07-27
K060898 PULSION PICCO PLUS, MODEL 8100 Pulsion Medical Systems AG DXG Class II 2006-07-25
K061962 SURGI-CUF REUSABLE, RS SERIES Ethox International DXQ Class II 2006-07-25
K061743 VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 Maquet Cardiopulmonary, AG DTN Class II 2006-07-21
K061977 PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES Pinmed, Inc. DXH Class II 2006-07-21
K060675 ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS Envitec-Wismar GmbH DQA Class II 2006-07-17
K061710 CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS St Jude Medical DQY Class II 2006-07-14

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