meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
2008-06-18

Clearances · page 71 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K081052 OCCLUSION BALLOON CATHETER, MODEL VENOS Oscor, Inc. DYG Class II 2008-06-18
K080034 THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 Terumo Cardiovascular Systems Corp. DWF Class II 2008-06-17
K081454 GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE Possis Medical, Inc. MJN Class II 2008-06-13
K080366 DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES Zefon Intl. DXQ Class II 2008-06-09
K081032 TR-USB TELEPHONIC STETHOSCOPE Rnk Products, Inc. DQD Class II 2008-06-06
K073712 SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 Adroit Medical Systems, Inc. DWJ Class II 2008-06-06
K081305 MERCI RETRIEVER Concentric Medical, Inc. NRY Class II 2008-06-05
K081285 FINGER PULSE OXIMETER, MODEL 9560 Nonin Medical, Inc. DQA Class II 2008-06-05
K081417 FOXCROSS PTA CATHETER Abbott Vascular, Inc. LIT Class II 2008-06-04
K080763 TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT Talley Medical DWJ Class II 2008-05-30
K081035 AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 Osypka Medical, Inc. DSB Class II 2008-05-30
K063723 IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM Abiomed, Inc. KFM Class II 2008-05-30
K081257 CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR Card Guard Scientific Survival , Ltd. DSI Class II 2008-05-29
K081359 GENESIS ECP Scottcare Corporation DRN Class II 2008-05-29
K081045 DESTINATION RENAL GUIDING SHEATH Terumo Medical Corp. DYB Class II 2008-05-28
K080424 HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 Hygia Health Services, Inc. NLF Class II 2008-05-28
K073326 NRG TRANSSEPTAL NEEDLE Baylis Medical Co., Inc. DXF Class II 2008-05-28
K080551 UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE University of Utah Hospitals and Clinics JOW Class II 2008-05-28
K081220 MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. PNO Class II 2008-05-28
K080255 NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2008-05-23
K081046 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. DYB Class II 2008-05-21
K071889 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE GE Healthcare DSI Class II 2008-05-19
K080994 AMPLATZER TORQVUE EXCHANGE SYSTEM Aga Medical Corp. DQY Class II 2008-05-16
K081341 REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) Thomas Medical Products, Inc. DYB Class II 2008-05-14
K071130 HEARTRAK AF Universal Medical, Inc. DXH Class II 2008-05-14
K080769 INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C Somanetics Corp. MUD Class II 2008-05-14
K080337 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D Microlife Corp. DXN Class II 2008-05-13
K080891 REVOLUTION 45MHZ IVUS IMAGING CATHETER Volcano Corporation OBJ Class II 2008-05-12
K080238 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER Masimo Corporation DQA Class II 2008-05-12
K080177 WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2008-05-09
K080999 PAGEWRITER CARDIOGRAPH Philips Medical Systems DPS Class II 2008-05-09
K073592 OPTISTAR ELITE INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business DXT Class II 2008-05-07
K080824 BIO-CONSOLE 560 Medtronic Perfusion Systems DWA Class II 2008-05-07
K080988 SCOUTPRO CS LEAD INTRODUCER SYSTEM Biotronik, Inc. DQY Class II 2008-05-07
K073454 FINGERTIP PULSE OXIMETER, MODEL CMS-50C Contec Medical System Co., Ltd. DQA Class II 2008-05-05
K080605 SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL Curbell Electronics, Inc. DSA Class II 2008-05-05
K072696 ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 Shenzhen Ant Hi-Tech Industrial Co., Ltd. DXT Class II 2008-05-02
K071642 MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER Mediaid, Inc. DQA Class II 2008-05-02
K080924 MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 St. Jude Medical, Cardiac Rhythm Management Divisi DRB Class II 2008-04-30
K080392 EndoWave Infusion System Ekos Corp. QEY Class II 2008-04-30
K080621 FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 European Custom Manufacturing BV DSA Class II 2008-04-29
K080925 FOX PLUS PTA CATHETER Abbott Vascular, Inc. LIT Class II 2008-04-28
K080141 PC ECG 1200W SYSTEM Norav Medical , Ltd. MWI Class II 2008-04-25
K080151 ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 Angioscore, Inc. PNO Class II 2008-04-25
K072932 INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 Infraredx, Inc. OGZ Class II 2008-04-25
K072923 ZOLL E SERIES DEFIBRILLATOR Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2008-04-24
K080472 SEDAT MYSHELL LITE Sedat DTL Class II 2008-04-23
K080425 CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 Biosense Webster, Inc. DRF Class II 2008-04-23
K080274 AMBULO 2400 Tiba Medical, Inc. DXN Class II 2008-04-23
K080670 MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM Atcor Medical DSK Class II 2008-04-23
K080232 ZOLL E SERIES 12SL, ANALYSIS OPTION Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2008-04-23
K073166 ENDOWAVE INFUSION SYSTEM Ekos Corp. KRA Class II 2008-04-22
K080757 AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM Aga Medical Corp. DQY Class II 2008-04-18
K080774 CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) Terumo Cardiovascular Systems Corp. KFM Class II 2008-04-17
K073585 INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 Vascular Solutions, Inc. DQO Class II 2008-04-17
K080863 TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE MicroVention, Inc. DQX Class II 2008-04-17
K073710 INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 Intouch Technologies DRG Class II 2008-04-11
K073716 LIFE+CEL OR LIFECEL BATTERY Amco International Manufacturing & Design, Inc. MKJ Class III 2008-04-11
K080884 QHRV 1 - HEALTH ASSESSMENT SYSTEM Medtechs, LLC DPS Class II 2008-04-11
K072460 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE Abbott Vascular, Inc. DQX Class II 2008-04-11
K060387 PHYSIOFLOW SYSTEM Vasocom, Inc. DSB Class II 2008-04-10
K080360 ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER Endologix, Inc. DQY Class II 2008-04-08
K080806 ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 Possis Medical, Inc. QEZ Class II 2008-04-04
K072583 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 Maquet Cardiopulmonary, AG DTR Class II 2008-04-04
K080789 BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 Sejoy Electronics & Instruments Co., Ltd. DXN Class II 2008-04-03
K080192 HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MSX Class II 2008-04-03
K073445 CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 Taidoc Technology Corporation DXN Class II 2008-04-02
K073434 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. DYB Class II 2008-04-01
K073519 QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 Kensey Nash Corp. QEZ Class II 2008-03-28
K073550 PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION Nihon Kohden America, Inc. MHX Class II 2008-03-28
K080264 MODIFICATION TO: FOX PLUS PTA CATHETER Abbott Vascular-Vascular Solutions LIT Class II 2008-03-26
K072329 SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED Biotronik, Inc. DQY Class II 2008-03-25
K080157 DASH 2500 PATIENT MONITOR Ge Medical Systems Information Technologies MHX Class II 2008-03-24
K080495 SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 Philips Medical Systems MHX Class II 2008-03-24
K080154 ACUITY UNIVERSAL CUTTER Cardiac Pacemakers, Inc. DQY Class II 2008-03-20
K080563 RUNTHROUGH NS EXTENSION WIRE Terumo Medical Corp. DQX Class II 2008-03-20
K071468 CLARIVEIN CATHETER Vascular Insights, LLC KRA Class II 2008-03-20
K073227 SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 Aiia Communication, Inc. MNW Class II 2008-03-20
K072527 AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 Zoll Circulation DRM Class II 2008-03-19
K080461 STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 Philips Medical Systems MLD Class II 2008-03-13
K073260 LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 Device Partners International DTL Class II 2008-03-13
K073324 MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R Medtronic, Inc. KRH Class II 2008-03-13
K072864 ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM St. Jude Medical, Cardiac Rhythm Management Divisi DRB Class II 2008-03-13
K080500 MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 Acumen Medical, Inc. DYB Class II 2008-03-13
K080415 DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. DYB Class II 2008-03-07
K073374 COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET William Cook Europe Aps DTK Class II 2008-03-07
K071763 AMADEUS ADAPTIVE COMPRESSION THERAPY Convatec JOW Class II 2008-03-07
K073028 VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30 Venowave, Inc. JOW Class II 2008-03-07
K072719 CONVOY ADVANCED DELIVERY SHEATH Boston Scientific Corp DYB Class II 2008-03-07
K071244 MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF Medline Industries, Inc. DXQ Class II 2008-03-05
K073474 CAPIOX CIRCUIT CONNECTORS Terumo Corp. DTL Class II 2008-03-05
K073544 PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES Rj Medical, Inc. KRD Class II 2008-03-05
K073627 FLEXOR EVAC ASPIRATION CATHETER Cook, Inc. QEZ Class II 2008-03-04
K080421 HEART SYNC, MODELS C-100 AND T-100 Heart Sync, LLC MKJ Class III 2008-02-29
K073380 SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI Sorin Group Italia S.R.L. DTZ Class II 2008-02-29
K073407 PACIFICA Or-Nim Medical , Ltd. MUD Class II 2008-02-28
K073528 VENA CAVA FILTER Cook Incorporated DTK Class II 2008-02-27
K073620 GUARDIAN HEMOSTASIS VALVE Zerusa Limited DTL Class II 2008-02-27
K072812 PHILIPS HEARTSTART SMARTPADS III Philips Medical Systems MKJ Class III 2008-02-26
K080289 1500 PRO Omron Healthcare, Inc. DXN Class II 2008-02-26

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