meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
53
Latest Decision
2011-10-14

Clearances · page 57 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112771 BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG Sorin Group Italia S.R.L. DTN Class II 2011-10-14
K112335 BANTAM CATHETER (280MM BALLOON LENGTHS) ClearStream Technologies , Ltd. DQY Class II 2011-10-12
K111200 MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM GE Healthcare DQK Class II 2011-10-12
K112652 SURESIGNS VS2+ -SURESIGNS VSI Philips Medical Systems DXN Class II 2011-10-11
K112629 ONSET ACCESS CATHETER SYSTEM Onset Medical Corporation DQY Class II 2011-10-11
K111404 HUIBAO BODY FAT SCALE Zhongshan Huibao Weighing Apparatus Co., Ltd. MNW Class II 2011-10-07
K111320 GLOBALCARDIO Cardiocomm Solutions, Inc. DSH Class II 2011-10-07
K112579 WILDCAT 5F GUIDEWIRE SUPPORT CATHETER Avinger, Inc. DQY Class II 2011-10-06
K103643 ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) Ascot Technologies, Inc. DRG Class II 2011-10-06
K112571 XL EXTRACTION CATHETER Vascular Solutions, Inc. QEZ Class II 2011-10-06
K112007 CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 Biosense Webster, Inc. DQK Class II 2011-10-05
K111905 INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN DXJ Class II 2011-10-04
K103651 CARDIOMED Cardio Medical Products, Inc. LDD Class II 2011-10-04
K111606 PINNACLE PRECISION ACCESS SYSTEM Terumo Medical Corp. DYB Class II 2011-10-03
K111899 ARMADA 35/35LL PTA CATHETER Abbott Vascular LIT Class II 2011-10-03
K111644 MOBICATH TRANSSEPTAL NEEDLE Great Batch Medical DRC Class II 2011-10-03
K112320 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR Health & Life Co., Ltd. DXN Class II 2011-09-30
K101273 DYNAMIC ECG SYSTEM MODEL TLC5000 Contec Medical System Co., Ltd. MLO Class II 2011-09-30
K111943 AGILLS PF DELIVERY SYSTEM St. Jude Medical, Cardiac Rhythm Management Divisi DYB Class II 2011-09-29
K110741 SCEPTER C OCCLUSION BALLOON CATHETER MicroVention, Inc. MJN Class II 2011-09-29
K112525 D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS Parexel International DTM Class II 2011-09-29
K111837 RADIAL ARTERY COMPRESSION TOURNIQUET Lepu Medical Technology (Beijing) Co., Ltd. DXC Class II 2011-09-27
K112232 REPROCESSED ELECTROPHYSIOLOGY CATHETERS Stryker Sustainability Solutions NLH Class II 2011-09-26
K112482 SELECTRA SLITTER TOOL Biotronik, Inc. DQY Class II 2011-09-26
K111839 SELECTRA ACCESSORY KIT Biotronik, Inc. DQY Class II 2011-09-26
K110878 RHYTHMVIEW (TM) Topera, Inc. DQK Class II 2011-09-23
K111888 MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS Masimo Corporation DQA Class II 2011-09-23
K112431 DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Electronics Co., Ltd. DPS Class II 2011-09-22
K112448 PULSIOFLEX Pulsion Medical Systems, Inc. DXG Class II 2011-09-22
K112645 RADIFORCE LARGE MONITOR SYSTEM Eizo GmbH DXJ Class II 2011-09-22
K112225 SORIN CENTRIFUGAL PUMP 5 (CP5) Sorin Group Deutschland GmbH DWA Class II 2011-09-20
K110493 TANDEMHEART PUMP Cardiacassist, Inc. KFM Class II 2011-09-20
K111720 AVIAFIT Flowmedic , Ltd. JOW Class II 2011-09-16
K111490 MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS Ev3, Inc. KRA Class II 2011-09-16
K112372 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC DSP Class II 2011-09-15
K112360 QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES Maquet Cardiopulmonary, AG DTZ Class II 2011-09-15
K112465 VITAL SIGNS MONITOR Advanced Instruments, Inc. DQA Class II 2011-09-14
K110891 THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. DQY Class II 2011-09-13
K112047 AMCOM COMMTECH MESSENGER Amcom Software,Inc. MSX Class II 2011-09-13
K111438 REKA E100 Reka Pte, Ltd. DPS Class II 2011-09-12
K111704 AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX Avinger, Inc. DQY Class II 2011-09-09
K112327 SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES Cardiac Assist, Maquet Cardiovascular, LLC DSP Class II 2011-09-09
K102633 BIOTEQ ANGIOGRAPHIC CATHETER Bioteque Corp. DQO Class II 2011-09-09
K101986 ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE Asahi Intecc Co., Ltd. DQX Class II 2011-09-09
K112329 OMNI PATIENT MONITOR Infinium Medical MWI Class II 2011-09-08
K110429 PROSIM 4, PROSIM 6, PROSIM 8 Fluke Biomedical DRT Class II 2011-09-02
K103808 SAPPHIRE NC Orbusneich Medical, Inc. LOX Class II 2011-09-01
K112311 ALP 501 RB PUMP SYSTEM Currie Medical Specialties, Inc. JOW Class II 2011-09-01
K112239 STEERABLE GUIDE CATHETER Abbott Vascular DRA Class II 2011-08-31
K112182 ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. PNO Class II 2011-08-26
K112235 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING Airstrip Technologies, LP MWI Class II 2011-08-26
K110977 VESOFLOW Caremed Supply, Inc. JOW Class II 2011-08-25
K102511 MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT C.R. Bard, Inc. DTK Class II 2011-08-24
K111805 ECG SERIES ELECTROCARDIOGRAPH Advanced Instrumentations, Inc. DPS Class II 2011-08-24
K103706 THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR Applied Cardiac Systems, Inc. QYX Class II 2011-08-24
K111917 NUVANT, MOBILE CARDIAC TELEMETRY Corventis, Inc. QYX Class II 2011-08-24
K110584 ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE Asahi Intecc Co., Ltd. MOF Class II 2011-08-22
K110689 INBODY Biospace Corporation Limited MNW Class II 2011-08-19
K112124 MICROCATHETER Navilyst Medical, Inc. DQO Class II 2011-08-19
K110076 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER Sterilmed, Inc. OWQ Class II 2011-08-18
K111594 ZOLL E SERIES Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2011-08-17
K111987 FIBERNET EMBOLIC PROTECTION DEVICE Lumen Biomedical, Inc. NTE Class II 2011-08-17
K111284 FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM Ostial Corporation LOX Class II 2011-08-17
K112308 CROSSER RECANALIZATION SYSTEM C.R. Bard, Inc. PDU Class II 2011-08-17
K112281 GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX Trireme Medical, Inc. DQY Class II 2011-08-17
K112103 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM Boston Scientific Corp KRD Class II 2011-08-12
K111338 WILDCAT CATHETER Avinger, Inc. PDU Class II 2011-08-11
K111963 BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER Bridgepoint Medical DQY Class II 2011-08-10
K103657 SAPPHIRE Orbusneich Medical, Inc. LOX Class II 2011-08-09
K110813 HEADWAY 27 MICROCATHETER MicroVention, Inc. DQY Class II 2011-08-05
K112135 ECG-6 SERIES ELECTROCARDIOGRAPH Advanced Instrumentations, Inc. DPS Class II 2011-08-05
K111043 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER Boston Scientific Corp OBJ Class II 2011-08-04
K111705 EKOSONIC ENDOVASCULAR SYSTEM Ekos Corporation QEY Class II 2011-08-03
K103796 TELEMEDCARE HEALTH MONITOR Telemedcare Pty, Ltd. DRG Class II 2011-08-03
K111288 ANCHORWIRE GUIDEWIRE Lake Region Medical DQX Class II 2011-08-02
K103802 TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR GE Healthcare Finland Oy DQA Class II 2011-08-02
K111686 A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS A&D Company, Ltd. DXN Class II 2011-08-01
K111395 PRIMEWIRE PRESTIGE PLUS Volcano Corporation DQX Class II 2011-08-01
K111745 KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER Card Guard Scientific Survival , Ltd. DSH Class II 2011-08-01
K111160 INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) Intricon Datrix Corporation DSI Class II 2011-08-01
K111334 BENELLI ACCESS DEVICE Vascular Solutions, Inc. DQY Class II 2011-08-01
K111556 GLIDECROSS SUPPORT CATHETER Terumo Medical Corp. DQY Class II 2011-07-29
K111884 OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. MGZ Class II 2011-07-29
K110723 M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS Masimo Corporation NLF Class II 2011-07-28
K110156 AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, Contec Medical System Co., Ltd. DXN Class II 2011-07-27
K111972 AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF Medtronic, Inc. KFM Class II 2011-07-27
K111187 PATCH, PLEDGET AND INTRACARDIAC Cormatrix Cardiovascular, Inc. DXZ Class II 2011-07-26
K111388 DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM Cardiovascular Systems, Inc. MCW Class II 2011-07-26
K103285 DIXTAL DZ-4100 SERIES PULSE OXIMETER Dixtal Medical, Inc. DQA Class II 2011-07-25
K111263 CXI TRIFORCE Cook Incorporated KRA Class II 2011-07-25
K110987 CARDIAC TRIGGER MONITOR Ivy Biomedical Systems, Inc. DRT Class II 2011-07-22
K111750 EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. DQY Class II 2011-07-21
K110922 PATIENT MONITOR Edan Instruments, Inc. MHX Class II 2011-07-20
K111380 NEURON MAX SYSTEM Penumbra, Inc. DQY Class II 2011-07-19
K111147 MEDLINE VESSEL CANNULA Medline Industries, Inc. DWF Class II 2011-07-19
K111417 THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, Inc. DYB Class II 2011-07-15
K110928 BODY ANALYSIS SCALE, MODEL BG 17 Shenzhen Healthcare Electronic Technology Co., Ltd. MNW Class II 2011-07-15
K111416 FALCON Viasonix , Ltd. JOP Class II 2011-07-15
K110328 ACG-8511 PORTABLE ECG MONITOR Andon Health Co, Ltd. DPS Class II 2011-07-15
K103685 PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA Beijing Rongrui-Century Scie. & Tech. Co., Ltd. DQA Class II 2011-07-15

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