meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2012-01-04

Clearances · page 56 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113187 AVIVO MOBILE PATIENT MANAGEMENT Corventis, Inc. MHX Class II 2012-01-04
K111403 MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES Masimo Corporation DQA Class II 2011-12-30
K112216 U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM Taidoc Technology Corporation DXN Class II 2011-12-22
K111159 HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME Cardiocomm Solutions, Inc. DPS Class II 2011-12-22
K111617 PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 Acare Technology Co., Ltd. DQA Class II 2011-12-22
K113176 MYSENSE HEART Cardiac Science Corporation DSH Class II 2011-12-21
K113493 TCX-I REMOTE CARE MANAGEMENT SYSTEM Bl Healthcare, Inc. DRG Class II 2011-12-21
K112657 AUREFLO MONITORING SYSTEM Transonic Systems, Inc. DPW Class II 2011-12-21
K112274 U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM Taidoc Technology Corporation DXN Class II 2011-12-21
K112521 FUKUDA DENSHI VASERA MODEL VS-1500 Fukuda Denshi USA, Inc. DXN Class II 2011-12-21
K113468 ELM PTA BALLON DILATATION CATHETER Creagh Medical, Ltd. LIT Class II 2011-12-20
K112587 ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, Terumo Cardiovascular Systems Corp. DWB Class II 2011-12-19
K110603 HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) I.E.M. GmbH DXN Class II 2011-12-16
K113133 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE Medrad, Inc. DXT Class II 2011-12-15
K113105 TEMPUSIC PATIENT MONITOR Remote Diagnostic Technologies , Ltd. MWI Class II 2011-12-15
K111738 CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) Trireme Medical, Inc. DQY Class II 2011-12-14
K112683 SMI CARDIOVASCULAR PACH Solimas Medical, Inc. DXZ Class II 2011-12-14
K112382 TERUMO ASPRIATION CATHETER Terumo Medical Corporation QEZ Class II 2011-12-14
K112203 COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST Mirador Biomedical, Inc. DRS Class II 2011-12-14
K112637 NETKONNECT REMOTE NETWORK EXTENSION Nihon Kohden MHX Class II 2011-12-09
K112229 SARN CENTRIFUGAL PUMP Terumo Cardiovascular Systems KFM Class II 2011-12-09
K112513 EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER Natec Medical , Ltd. LIT Class II 2011-12-09
K111826 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2011-12-09
K111830 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO Andon Health Co, Ltd. DXN Class II 2011-12-09
K113300 ATB ADVANCE PTA DILATATION CATHETER Cook, Inc. LIT Class II 2011-12-09
K113182 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER Edwards Lifesciences, LLC DXC Class II 2011-12-07
K112565 NOVAPORT ONE VASCULAR ACCESS CANNULA Novalung GmbH DWF Class II 2011-12-06
K113213 LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 Biosense Webster, Inc. DRF Class II 2011-12-05
K112845 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Microlife Intellectual Property GmbH DXN Class II 2011-12-05
K112559 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM Medapps, Inc. DRG Class II 2011-12-02
K111922 VOCARE MYHEALTH TABLET Vocare, Inc. DRG Class II 2011-12-02
K113235 PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS Medtronic, Inc. DXS Class II 2011-12-02
K113428 ANGIOJET ULTRA DVX THROMBECTOMY SET Medrad, Inc. QEZ Class II 2011-12-02
K112979 ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE Asahi Intecc Co., Ltd. MOF Class II 2011-12-01
K112082 GUIDELINER V2 CATHETER Vascular Solutions, Inc. DQY Class II 2011-12-01
K112697 CHARGER PTA BALLON DILATATION CATHETER Boston Scientific LIT Class II 2011-11-30
K113198 NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML Navilyst Medical, Inc. DXT Class II 2011-11-28
K112488 HOTDOG PATIENT WARMING SYSTEM Augustine Biomedical & Design, LLC DWJ Class II 2011-11-23
K113163 PENUMBRA SYSTEM MAX Penumbra, Inc. NRY Class II 2011-11-23
K111748 RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A Joy Long JOW Class II 2011-11-23
K110525 VITALOGRAPH MODEL 7100 - VITALOJAK Vitalograph (Ireland) , Ltd. DSH Class II 2011-11-23
K112273 ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR Accumed Healthcare (Shanghai), Inc. DXN Class II 2011-11-22
K110893 VTRUST FINGER TYPE PULSE OXIMETER Taidoc Technology Corporation DQA Class II 2011-11-22
K112647 BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM Wistron Corporation DXN Class II 2011-11-22
K112544 UNIMED BLOOD PRESSURE CUFF Unimed Medical Supplies, Inc. DXQ Class II 2011-11-22
K112687 CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES Welch Allyn, Inc. MWI Class II 2011-11-22
K112270 ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR Accumed Healthcare (Shanghai), Inc. DXN Class II 2011-11-22
DEN100026 APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE Aptus Endosystems, Inc. OTD Class II 2011-11-21
K112050 SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER Biosense Webster, Inc. OBJ Class II 2011-11-18
K112219 TAPAS CATHETER Thermopeutix, Inc. MJN Class II 2011-11-18
K112554 TRANSRADIAL ARTERY ACCESS DEVICES Teleflexmedical, Inc. DYB Class II 2011-11-18
K113234 MOBCARDIO SYSTEM Mobhealth Incorporation DPS Class II 2011-11-17
K113125 INTELLIVUE MX40 PATIENT MONITOR Philips Medical Systems DSI Class II 2011-11-17
K113112 CLEARWAY RX NB CATHETER Atrium Medical Corp. DQY Class II 2011-11-17
K110770 HEALTHTRACKER Wistron Corporation DXN Class II 2011-11-16
K111773 RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE Renu Medical, Inc. NLF Class II 2011-11-16
K103058 MULTIFUNCTION KEITO Aguiflai Iberica S.L. DXN Class II 2011-11-10
K112838 VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS Compression Therapy Concepts, Inc. JOW Class II 2011-11-10
K110463 PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS) Norav Medical , Ltd. MWI Class II 2011-11-10
K111487 NH-301 AMBULATORY ECG ANALYSIS SOFTWARE Norav Medical Corp. MLO Class II 2011-11-10
K102925 NEXGEN EXPANDABLE CATHETER Nexgen Medical Systems, Inc. DYB Class II 2011-11-10
K112303 RUBICON SUPPORT CATHETER Boston Scientific DQY Class II 2011-11-09
K110276 POWERPRESS UNIT Hanuri Distribution, Inc. JOW Class II 2011-11-09
K113110 AXERA ACCESS SYSTEM Arstasis, Inc. DYB Class II 2011-11-09
K112190 PATIENT MONITOR Mediana Co., Ltd. MHX Class II 2011-11-09
K112688 ENSITE VELOCITY SYSTEM V.3.0 St Jude Medical DQK Class II 2011-11-09
K112601 INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER Intricon Datrix Corporation MWJ Class II 2011-11-09
K112957 HI-TORQUE POWERTURN Abbott Vascular-Cardiac Therapies DQX Class II 2011-11-08
K112282 M VISUM ALERT ALARM MANAGEMENT SYSTEM Mvisum, Inc. MSX Class II 2011-11-04
K100811 IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 ImpediMed Limited OBH Class II 2011-11-04
K112381 HI TORQUE CONNECT GUIDEWIRE Lake Region Medical DQX Class II 2011-11-03
K112262 REFLEX BALLON GUIDE CATHETER Reverse Medical Corporation DQY Class II 2011-11-02
K112185 FOURSNARE VASCULAR RETRIEVAL SNARE Cook, Inc. MMX Class II 2011-11-02
K102378 VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI Vectracor, Inc. DPS Class II 2011-11-02
K112962 SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) Spacelabs Medical, Inc. MHX Class II 2011-11-02
K112932 TRANSTEK Zhongshan Transtek Electronics Co., Ltd. MNW Class II 2011-11-01
K112951 BODY ANALYSIS SCALE Shenzhen Healthcare Electronic Technology Co., Ltd. MNW Class II 2011-11-01
K111693 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems MKJ Class III 2011-10-28
K111723 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Ev3, Inc. MCW Class II 2011-10-27
K112917 ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID Medtronic, Inc. DQY Class II 2011-10-27
K111296 ZOLL RESCUENETLINK Zoll Medical Corporation, World Wide Headquarters MSX Class II 2011-10-27
K112631 VSI GUIDEWIRE Vascular Solutions, Inc. DQX Class II 2011-10-27
K111010 SPIDERFX EMBOLIC PROTECTION DEVICE Ev3, Inc. NTE Class II 2011-10-27
K111621 MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS Masimo Corporation DQA Class II 2011-10-26
K112828 REVIVE INTERMEDIATE CATHETER (REVIVE IC) Codman & Shurtleff, Inc. DQY Class II 2011-10-25
K110569 AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) Inovise Medical, Inc. MLO Class II 2011-10-24
K112497 MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT C.R. Bard, Inc. DTK Class II 2011-10-24
K112803 PATIENT MONITOR Guangdong Biolight Meditech Co., Ltd. MHX Class II 2011-10-24
K112292 REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER Stryker Sustainability Solutions NLH Class II 2011-10-21
K111854 AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER St. Jude Medical Systems AB DRG Class II 2011-10-21
K103791 PHYSIOGLOVE ES WITH ECG ANALYSIS Commwell , Ltd. DPS Class II 2011-10-21
K111542 DELTEX MEDICAL CARDIOQ EDM Deltex Medical Limited DPW Class II 2011-10-20
K110315 NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE Nexgen Medical Systems, Inc. QEZ Class II 2011-10-20
K112269 OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE OSTAR MEDITECH CORP. DXN Class II 2011-10-20
K112323 CARDIA-CATH Millar Instruments, Inc. DXO Class II 2011-10-18
K112745 V-14 CONTROL WIRE GUIDEWIRE Boston Scientific Corporation DQX Class II 2011-10-18
K112384 ABDOMINAL TOURNIQUET SYSTEM Compression Works, LLC DXC Class II 2011-10-18
K112032 8FR TURBO - TANDEM SYSTEM Spectranetics Corp. DQY Class II 2011-10-17
K112694 EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER Edwards Lifesciences, LLC DXC Class II 2011-10-14
K112086 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE Medrad, Inc. DXT Class II 2011-10-14

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