meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
48
Latest Decision
2011-07-14

Clearances · page 58 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K094048 PERCUPRO MESSENGER BALLOON CATHETER Cardiosolutions, Inc. DYG Class II 2011-07-14
K103077 ECG PEN Meridian Dynamics Biomedical, Inc. DPS Class II 2011-07-13
K111652 MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR Microlife Intellectual Property GmbH DXN Class II 2011-07-13
K111850 VACCESS PTA DILATATION CATHETER C.R. Bard, Inc. DQY Class II 2011-07-13
K111747 ENDOLOGIX AFX INTRODUCER SYSTEM Endologix, Inc. DYB Class II 2011-07-12
K111601 HERO Medical Predictive Science Corp. DPS Class II 2011-07-08
K110044 FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM Foracare, Inc. DXN Class II 2011-07-07
K111619 MODIFIED CONCENTRIC MICROCATHETER Concentric Medical, Inc. DQO Class II 2011-07-06
K111215 ASCOM MOBILE MONITORING GATEWAY (MMG) Ascom (Sweden) AB MSX Class II 2011-07-05
K110809 WIRELESS MONITORING SYSTEM Carefusion 303, Inc. DRG Class II 2011-07-05
K102648 ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK Shenzhen Ant Hi-Tech Industrial Co., Ltd. MAV Class II 2011-07-01
K110643 MERIT MARQUIS FLOW SWITCH Merit Medical Systems, Inc. DQO Class II 2011-07-01
K111488 MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 Bridgepoint Medical DQX Class II 2011-06-30
K102856 SIROCCO THERMAL REGULATING SYSTEM Galmaz Biotech S.L. DWJ Class II 2011-06-30
K111498 FATHOM (TM) 14 STEERABLE GUIDEWIRE Boston Scientific Corp DQX Class II 2011-06-30
K111485 FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX Boston Scientific Corporation DQX Class II 2011-06-30
K111658 AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE Medtronic, Inc. KFM Class II 2011-06-28
K111180 VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY Vasomedical, Inc. DSH Class II 2011-06-28
K101692 PATIENT MONITOR Contec Medical System Co., Ltd. MHX Class II 2011-06-28
K110459 SUREFIRE INFUSION CATHETER SYSTEM Surefire Medical, Inc. DQO Class II 2011-06-24
K103520 CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING Edwards Lifesciences, LLC KRH Class II 2011-06-24
K111096 VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY Vasomedical, Inc. DSH Class II 2011-06-24
K110704 SENSI Diacoustic Medical Devices (Pty) , Ltd. DQD Class II 2011-06-24
K111657 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE Medtronic, Inc. KFM Class II 2011-06-23
K111138 THE PICC WAND (R) PEELABLE SAFETY INTRODUCER Access Scientific, Inc. DYB Class II 2011-06-22
K110980 CENTRIMAG RETURN CANNULA KIT Levitronix, LLC DWF Class II 2011-06-20
K110983 CENTRIMAG DRAINAGE CANNULA KIT Levitronix, LLC DWF Class II 2011-06-20
K103783 EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC Fiab Spa LDD Class II 2011-06-16
K111307 AZUR DETACHABLE 35 PLATINUM COIL SYSTEM MicroVention, Inc. KRD Class II 2011-06-15
K110953 VISENSIA, VISENSIA WITH ALERT Obs Medical MHX Class II 2011-06-15
K110001 SPACELABS PATHFINDER SL HOLTER ANALYZER Spacelabs Healthcare, Ltd. DQK Class II 2011-06-14
K110597 EV1000 CLINICAL PLATFORM Edwards Lifesciences DXG Class II 2011-06-14
K110374 MAX PULSE SYSTEM Medicore Co., Ltd. JOM Class II 2011-06-13
K102507 AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR Tz Medical, Inc. DSI Class II 2011-06-13
K103584 ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS Shenzhen Envisen Industry Co. Limited DQA Class II 2011-06-10
K110133 EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER Creganna-Tactx Medical LOX Class II 2011-06-10
K111092 ENGAGE/ENGAGE TR INTRODUCERS St Jude Medical DYB Class II 2011-06-09
K102496 POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS Cardiac Science Corporation MKJ Class III 2011-06-09
K111007 MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE Midwest Reprocessing Center, LLC NMD Class II 2011-06-08
K103637 ERKA. PERFECT-ANEROID Erka Kallmeyer Medizintechnik GmbH DXQ Class II 2011-06-08
K110693 PACEART OPTIMA SYSTEM SOFTWARE Medtronic, Inc. KRE Class II 2011-06-08
K102767 CARDIO XP Bionet Co., Ltd. DPS Class II 2011-06-03
K110645 BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR Sonosite,Inc. DSB Class II 2011-06-03
K103737 OMNI II PATIENT MONITOR Infinium Medical MWI Class II 2011-06-02
K111252 ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F Boston Scientific Corp DQY Class II 2011-06-02
K110617 MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER Abbott Vascular LOX Class II 2011-06-02
K111229 JETSTREAM G3 (R) SF 1.6 SYSTEM Pathway Medical Technologies, Inc. MCW Class II 2011-06-01
K110516 CONNEX VITAL SIGNS MONITOR 6000 SERIES Welch Allyn, Inc. MWI Class II 2011-06-01
K111295 .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS Boston Scientific Corporation LIT Class II 2011-05-31
K110957 M4 MONITOR Spectrum Medical, Llp DRY Class II 2011-05-31
K101681 TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 Zhongshan Transtek Electronics Co., Ltd. DXN Class II 2011-05-27
K110090 AFX INTRODUCER SYSTEM Endologix, Inc. DYB Class II 2011-05-26
K110132 MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies, Inc. DQK Class II 2011-05-25
K111182 ANGIOJET SOLENT OMNI THROMBECTOMY SET Medrad, Inc. QEZ Class II 2011-05-24
K103421 ARSTASIS DILATOR ADAPTER Arstasis, Inc. DRE Class II 2011-05-24
K110746 4D LV-ANALYSIS 3.0 Tomtec Imaging Systems GmbH DQK Class II 2011-05-24
K111384 LIFEBRIDGE Lifebridge Medizintechnik AG KFM Class II 2011-05-24
K103500 GORE EMBOLIC FILTER W. L. Gore & Associates, Inc. NTE Class II 2011-05-23
K111154 SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 Biotronik, Inc. DQY Class II 2011-05-23
K110803 SURESIGNS VSI VITAL SIGNS MONITOR Philips Medical Systems DXN Class II 2011-05-20
K111114 SURESIGNS VS2 VITAL SIGNS MONITOR Philips Medical Systems DXN Class II 2011-05-20
K110015 VITALSENS, AINGEAL, V-POD Intelesens Limited MHX Class II 2011-05-20
K111137 HYDROFIX VASO SHIELD Mimedx Group, Inc. OMR Class II 2011-05-20
K110872 WITHINGS BLOOD PRESSURE MONITOR Withings DXN Class II 2011-05-20
K103377 CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 Brivant, Ltd. DQX Class II 2011-05-18
K103812 MITRA-LIFT Sciencity Co., Ltd. KRH Class II 2011-05-18
K103765 MAC 600 RESTING ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies, Inc. DPS Class II 2011-05-17
K103094 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR Edwards Lifesciences, LLC DXG Class II 2011-05-17
K110774 ELECTRONIC SPHYGMOMANOMETER Contec Medical System Co., Ltd. DXN Class II 2011-05-13
K110540 TERUMO SUPPORT CATHETER Terumo Medical Corp. DQY Class II 2011-05-13
K103473 ZOLL RESCUENET EPCR MODEL RESCUENET EPCR ZOLL Medical Corporation DXJ Class II 2011-05-13
K110775 ELECTRONIC SPHYGMOMANOMETER Contec Medical Systems Co.,Ltd DXN Class II 2011-05-13
K110978 ONESTEP PEDIATRIC MFE'S ZOLL Medical Corporation MKJ Class III 2011-05-13
K110159 ACTIVECARE SFT Medical Compression Systems (Dbn) , Ltd. JOW Class II 2011-05-12
K110409 ASPIRA PLEURAL DRAINAGE SYSTEM C.R. Bard, Inc. DWM Class II 2011-05-11
K102725 CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M Bridge Medical, Inc. DQY Class II 2011-05-10
K110450 AGILIS NXT STEERABLE INTRODUCER St Jude Medical DYB Class II 2011-05-10
K110358 VENODYNE V810 Microtek Medical, Inc. JOW Class II 2011-05-05
K110549 ENSITE VELOCITY SYSTEM St Jude Medical DQK Class II 2011-05-05
K103764 REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 Medtronic, Inc. DSI Class II 2011-05-04
K110438 SENSILASE PAD-IQ Vasamed, Inc. DPW Class II 2011-05-04
K101991 WEBSTER DUO-DECAPOLAR CATHETER Biosense Webster, Inc. DRF Class II 2011-05-02
K102191 TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER Zhongshan Transtek Electronics Co., Ltd. MNW Class II 2011-05-02
K110909 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. Abbott Laboratories NTE Class II 2011-04-29
K110266 MAC 5500 HD, MAC 3500 Ge Medical Systems Information Technologies, Inc. DPS Class II 2011-04-29
K110903 PTS-X SIZING BALLOON CATHETER NuMED, Inc. MJN Class II 2011-04-29
K110845 IMPELLA CONTROLLER WITH FLOW CONTROL Abiomed, Inc. KFM Class II 2011-04-27
K110626 JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM Pathway Medical Technologies, Inc. MCW Class II 2011-04-20
K110461 SELECTRA CS LEAD INTRODUCER SYSTEM Biotronik, Inc. DQY Class II 2011-04-20
K110779 SPACELABS SMART DISCLOSURE SYSTEM Spacelabs Healthcare DQK Class II 2011-04-19
K110521 EVERON CENTRAL DISPLAY STATION (CDS) Earlysense, Ltd. MSX Class II 2011-04-19
K110148 WEXLER VASCULAR CLAMP SERIES Microsurgical Laboratories,Inc.Dba Wexler Surgical DXC Class II 2011-04-19
K102418 REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM Reverse Medical Corporation DQY Class II 2011-04-15
K100183 MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER Tanita Corp. MNW Class II 2011-04-15
K110767 ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. PNO Class II 2011-04-15
K101867 VICOR PD2I ANALYZER Vicor Technologies, Inc. DPS Class II 2011-04-14
K110319 EVERCROSS 0.035 OTW PTA DILATATION CATHETER Ev3, Inc. LIT Class II 2011-04-14
K110742 ONESTEP ADULT MULTI-FUNCTION ELECTRODE ZOLL Medical Corporation MKJ Class III 2011-04-13
K103336 MPS450 MULTIPARAMETER SIMULATOR Fluke Biomedical DRT Class II 2011-04-13
K110334 WALDO PATIENT MONITOR Waldo Health DRG Class II 2011-04-12

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