meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2014-05-21

Clearances · page 46 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133598 CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG DTQ Class II 2014-05-21
K140165 MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE Medtronic, Inc. DWF Class II 2014-05-20
K141015 INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT Philips Medizinsysteme Boeblingen GmbH, Cardiac AN MHX Class II 2014-05-19
K133853 VIEWFLEX XTRA ICE CATHETER Irvine Biomedical, Inc., A St. Jude Medical Company OBJ Class II 2014-05-19
K133014 DMS 300-2W HOLTER ECG RECORDER Diagnostic Monitoring Software MWJ Class II 2014-05-19
K133988 TEMPUS PRO EXTENDED FEATURES Remote Diagnostic Technologies , Ltd. MWI Class II 2014-05-16
K140287 AXERA RX ACCESS SYSTEM Arstasis, Inc. DYB Class II 2014-05-16
K141041 APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE Aptus Endosystems OTD Class II 2014-05-16
K132037 VITAL SIGNS MONITOR Mindray North America MWI Class II 2014-05-16
K140329 RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT Boston Scientific KRA Class II 2014-05-15
K133317 PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX Penumbra, Inc. NRY Class II 2014-05-13
K140755 ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS Medical Compression Systems (Dbn) , Ltd. JOW Class II 2014-05-08
K133064 MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 Envitec-Wismar GmbH DQA Class II 2014-05-02
K132038 ACCUTORR 7 VITAL SIGNS MONITOR Mindray North America MWI Class II 2014-05-02
K140185 OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE Avinger, Inc. PDU Class II 2014-05-01
K132617 MEDTRONIC INPUT PS INTRODUCER Medtronic, Inc. DYB Class II 2014-04-30
K133600 COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR Coeur, Inc. DXT Class II 2014-04-30
K133882 CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) Ge Medical Systems Information Technologies, Inc. DXJ Class II 2014-04-30
K133879 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. MUD Class II 2014-04-29
K140733 CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER Boston Scientific Corporation MTD Class II 2014-04-28
K133588 FORA CARE BLOOD PRESSURE MONITORING SYSTEM Foracare, Inc. DXN Class II 2014-04-25
K133237 GEL-BEAD EMBOLIZATION SPHERES Vascular Solutions, Inc. KRD Class II 2014-04-25
K140080 ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB Codman & Shurtleff, Inc. DQY Class II 2014-04-24
K131525 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC MKJ Class III 2014-04-24
K132077 PATIENT MONITOR Advanced Instrumentations, Inc. MHX Class II 2014-04-23
K133897 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc. OGZ Class II 2014-04-23
K140307 ENVOY GUIDING CATHETER Codman & Shurtleff, Inc. DQY Class II 2014-04-21
K133534 MCKESSON CARDIOLOGY ECG MOBILE Mckesson Israel , Ltd. DQK Class II 2014-04-18
K132075 PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) Mindray North America MHX Class II 2014-04-18
K133624 COMPASS CT, COMPASS CT PORT Mirador Biomedical DRS Class II 2014-04-18
K133998 ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING Angioscore, Inc. PNO Class II 2014-04-18
K132789 FLIP INTRODUCER ACCESS KIT Vascular Solutions, Inc. DYB Class II 2014-04-17
K140745 ENCORE 26 ADVANTAGE KIT Boston Scientific Corp MAV Class II 2014-04-17
K140406 DESTINO TWIST, STEERABLE GUIDING SHEATH Oscor, Inc. DYB Class II 2014-04-17
K140321 INITARY BETTER BLADDER-PEDIATRIC Circulatory Technology, Inc. DTN Class II 2014-04-17
K140288 TRUEPATH CTO DEVICE Boston Scientific Corp PDU Class II 2014-04-16
K140092 CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) Currie Medical Specialties, Inc. JOW Class II 2014-04-16
K140673 INSERTION TOOL Boston Scientific Corp DQX Class II 2014-04-16
K140475 ROTATING ADAPTERS Merit Medical Systems, Inc. DTL Class II 2014-04-16
K132930 MYHEALTHPOINT TELEHEALTH MANAGER Entra Health Systems DRG Class II 2014-04-14
K133923 MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET Reflectance Medical, Inc. MUD Class II 2014-04-11
K133903 BIO-PROBE TRANSDUCER (ADULT) Medtronic, Inc. DPT Class II 2014-04-10
K140339 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM Covidien MWI Class II 2014-04-10
K140042 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. MGZ Class II 2014-04-10
K140047 LEXICONTURE MECHANICAL DILATOR SHEATH SET Spectranetics Corp. DRE Class II 2014-04-09
K133155 HYDROPHILIC COATED GUIDEWIRE Lake Region Medical DQX Class II 2014-04-07
K130878 CLOUDEKG Makromed, Inc. DXH Class II 2014-04-04
K132914 ACUITY PRO LEAD DELIVERY SYSTEM Boston Scientific DQY Class II 2014-04-03
K132447 VITALCONNECT PLATFORM BY VITAL CONNECT INC. Vitalconnect, Inc. DRG Class II 2014-04-03
K132488 ZOLL CODE WRITER ZOLL Medical Corporation DXJ Class II 2014-04-03
K140420 VADO STEERABLE SHEATH Kalila Medical, Inc. DYB Class II 2014-04-01
K134044 EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM Cardio Tek, BV DQK Class II 2014-03-31
K140201 AXERA 2 ACCESS SYSTEM Arstasis, Inc. DYB Class II 2014-03-28
K133631 LEXIPLIANT DILATOR SHEATH SET Spectranetics Corporation DRE Class II 2014-03-27
K140485 MANDREL GUIDEWIRE Lake Region Medical DQX Class II 2014-03-27
K133539 TOTAL ACROSS Medtronic Vascular DQY Class II 2014-03-26
K140637 PEREGRINE SYSTEM INFUSION CATHETER Ablative Solutions, Inc. KRA Class II 2014-03-26
K133125 WITHINGS BLOOD PRESURE MONITOR Withings DXN Class II 2014-03-24
K131971 IM60/IM70 PATIENT MONITOR Edan Instruments, Inc. MHX Class II 2014-03-20
K132206 MELYS ATRIAL FIBRILLATION SCREENING MONITOR Advanced Fluidics, LLC DXH Class II 2014-03-19
K140398 EMBOL-X INTRODUCER SHEATH Edwards Lifesciences, LLC DYB Class II 2014-03-19
K133865 ASAHI GAIA FIRST, SECOND, THIRD Asahi Intecc Co., Ltd. DQX Class II 2014-03-18
K133252 HEALTHINTERLINK BEACON Healthinterlink, LLC DRG Class II 2014-03-14
K140318 SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER Biosense Webster OBJ Class II 2014-03-12
K131916 BPROSOFT CASP PC SOFTWARE Healthstats International Pte. , Ltd. DXN Class II 2014-03-11
K140327 ULTIMUM EV HEMOSTASIS INTRODUCER St Jude Medical DYB Class II 2014-03-11
K140286 OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER Cordis, A Johnson & Johnson Co. DTK Class II 2014-03-07
K131627 CATHETER INTRODUCER SHEATH Edwards Lifesciences, LLC DYB Class II 2014-03-06
K133618 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2014-03-05
K133445 ANGIOVAC CANNULA Vortex Medical, Inc. DWF Class II 2014-03-05
K131900 CONTEC ELECTROCARDIOGRAPH Contec Medical System Co., Ltd. DPS Class II 2014-03-05
K140208 FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII Edwards Lifesciences, LLC DWF Class II 2014-03-05
K133619 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2014-03-05
K133117 ANDON BLOOD PRESSURE CUFF Andon Health Co, Ltd. DXQ Class II 2014-03-04
K131788 HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE Healthstats International Pte. , Ltd. DXN Class II 2014-03-04
K133028 RITHM ID ELECTROPHYSIOLOGY CATHETER Synaptic Medical Limited DRF Class II 2014-03-04
K133383 HEM-7320 Omron Healthcare, Inc. DXN Class II 2014-03-04
K133119 FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS Arjohuntleigh Polska SP Z.O.O. JOW Class II 2014-02-28
K132810 GLADIATOR ELITE PTA BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 2014-02-28
K133999 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems, Inc. MCW Class II 2014-02-28
K133090 OXICARE FINGERTIP PULSE OXIMETER Delbio Incorporation DQA Class II 2014-02-28
K131876 M SERIES PATIENT MONITOR Mid-Link Consulting Co, Ltd. MHX Class II 2014-02-27
K132811 SARNS SOFT-FLOW EXTENDED AORTIC CANNULA Terumo Cardiovascular Systems Corporation DWF Class II 2014-02-27
K131770 PRESSURE CONNECTING TUBE Shenzhen Ant Hi-Tech Industrial Co., Ltd. DQO Class II 2014-02-26
K140034 SUREFIRE GUIDING CATHETER Surefire Medical, Inc. DQY Class II 2014-02-26
K131503 SE-601 SERIES ELECTROCARDIOGRAPH Edan Instruments, Inc. DPS Class II 2014-02-25
K133501 LEADLINER CS LEAD DELIVERY SYSTEM Vascular Solutions, Inc. DQY Class II 2014-02-25
K133177 MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2014-02-25
K133447 EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES Celonova Biosciences, Inc. NAJ Class II 2014-02-24
K133625 AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & Codman & Shurtleff, Inc. MOF Class II 2014-02-24
K132229 OMNI PATENT MONITORS Infinium Medical MWI Class II 2014-02-21
K133576 MONITOR B40 Ge Medical Systems China Co., Ltd. MHX Class II 2014-02-21
K132402 SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM Nonin Medical, Inc. DQA Class II 2014-02-21
K131041 ADVANCED PERFUSION SYSTEM 1 Terumo Cardiovascular Systems Corp. DTQ Class II 2014-02-20
K131772 CANTATA(R) 2.9 MICROCATHETER Cook, Inc. KRA Class II 2014-02-20
K140181 MEDOS HILITE INFANT OXYGENATOR Medos Medizintechnik AG DTZ Class II 2014-02-19
K140177 MEDOS HILITE OXYGENATOR Medos Medizintechnik AG DTZ Class II 2014-02-18
K131898 A SERIES AND Q SERIES PATIENT MONITORS Guangdong Biolight Meditech Co., Ltd. MWI Class II 2014-02-18
K132451 SARNS SOFT-FLOW AORTIC CANNULA Terumo Cardiovascular Systems Corp. DWF Class II 2014-02-18
K132649 REVEAL LINQ INSERTABLE CARDIAC MONITOR Medtronic, Inc. MXD Class II 2014-02-14

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