meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
53
Latest Decision
2008-02-26

Clearances · page 72 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K080206 MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM Radi Medical Systems AB DXC Class II 2008-02-26
K080342 NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES Nihon Kohden America, Inc. MHX Class II 2008-02-26
K080144 MANDREL GUIDEWIRES OR M-WIRES Lake Region Mfg., Inc. DQX Class II 2008-02-26
K073036 FORE-SIGHT, MC-2000 SERIES Cas Medical Systems, Inc. DQA Class II 2008-02-25
K072860 YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 Ya Horng Electronic Co., Ltd. DXN Class II 2008-02-25
K073079 THUMPER, MODEL: 1008 Michigan Instruments, Inc. DRM Class II 2008-02-14
K071432 SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE Fox Hollow Technologies MCW Class II 2008-02-12
K073024 MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES Masimo Corporation DQA Class II 2008-02-08
K070126 OCCLUSION BALLOON CATHETER Sentreheart, Inc. DQY Class II 2008-02-08
K080169 HEARTSTRING III PROXIMAL SEAL SYSTEM Guidant Corporation, Cardiac Surgery DXC Class II 2008-02-08
K080173 STAR 55 Larsen & Toubro Limited MWI Class II 2008-02-08
K073162 SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING Kensey Nash Corporation DQX Class II 2008-02-08
K072947 SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS ClearStream Technologies , Ltd. LIT Class II 2008-02-08
K080091 MODIFICATION TO:HEALTH BUDDY APPLIANCE Health Hero Network, Inc. DRG Class II 2008-02-05
K070985 AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC Osypka Medical, Inc. DSB Class II 2008-02-01
K080106 SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE Leonhard Lang GmbH DRX Class II 2008-02-01
K073200 GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 Vascular Solutions, Inc. DQO Class II 2008-02-01
K072798 VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER Abbott Vascular-Vascular Solutions LIT Class II 2008-01-31
K073563 MODIFICATION TO PROXIS SYSTEM St Jude Medical NFA Class II 2008-01-31
K073559 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II Edwards Lifesciences Research Medical DQR Class II 2008-01-31
K071778 HERO VASCULAR ACCESS DEVICE Graftcath, Inc. DSY Class II 2008-01-30
K070514 ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO Aln Implants Chirurgicaux DTK Class II 2008-01-30
K073655 PEGASUS STEERABLE (PTCA) GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2008-01-28
K072114 IMPULSE 6000D/7000DP Fluke Biomedical DRL Class II 2008-01-28
K073656 OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM Hypermed, Inc. MUD Class II 2008-01-25
K073625 MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM Ge Healthcare Systems Information Technologies DPS Class II 2008-01-25
K073441 ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 Possis Medical, Inc. QEZ Class II 2008-01-24
K072596 LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 Amco International Manufacturing & Design, Inc. MKJ Class III 2008-01-24
K071774 JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 Maquet Cardiopulmonary, AG DTZ Class II 2008-01-23
K062970 I-PAD Cu Medical Systems, Inc. MKJ Class III 2008-01-22
K072770 TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) Oscor, Inc. LDF Class II 2008-01-22
K071631 NICOM ELECTRODES Cheetah Medical, Inc. DXG Class II 2008-01-18
K072662 CHEETAH RELIANT, CHEETAH ACTIVE Cheetah Medical, Inc. DSB Class II 2008-01-16
K073318 BIPORE BALLOON DILATION CATHETER Bipore, Inc. LIT Class II 2008-01-16
K080036 PORTABLE ECSCOPE 12I Dyansys, Inc. DPS Class II 2008-01-16
K073090 RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J C.R. Bard, Inc. DTK Class II 2008-01-15
K073473 EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 Volcano Corporation OBJ Class II 2008-01-14
K072825 FINGERTIP PULSE OXIMETER, MODEL MD300I Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2008-01-14
K073289 MICROSHEATH XL CATHETERS Flowcardia, Inc. DQY Class II 2008-01-11
K073630 MODIFICATION TO: BPCARD, MODEL Z-7000-0700 Qrs Diagnostic, LLC DXN Class II 2008-01-11
K073198 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1) Microlife Intellectual Property GmbH DXN Class II 2008-01-11
K072385 HEARTEVENT, MODEL AT Diagnostic Devices Pty, Ltd. DXH Class II 2008-01-11
K071939 HYDROCOIL EMBOLIC SYSTEMS (HES) MicroVention, Inc. KRD Class II 2008-01-11
K073462 MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES Ge Medical Systems Information Technologies MHX Class II 2008-01-11
K073038 CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B Carematix, Inc. DRG Class II 2008-01-11
K073152 PC-180 / PRINCE 180 EASY ECG MONITOR Shenzhen Creative Industry Co., Ltd. DSH Class II 2008-01-10
K072834 SIBEL SA VASCULAR CLAMP Surgical Instruments Belgium SA DXC Class II 2008-01-09
K070945 ASAHI PTCA GUIDE WIRE Asahi Intecc Co., Ltd. DQX Class II 2008-01-09
K073472 VACCESS PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. LIT Class II 2008-01-09
K073082 CPS COURIER GUIDEWIRE Brivant, Ltd. DQX Class II 2008-01-09
K072581 PM-60 PULSE OXIMETER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DQA Class II 2008-01-08
K072745 Y-GLIDE Thomas Medical Products, Inc. DTL Class II 2008-01-04
K070605 JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING Maquet Cardiopulmonary, AG DTN Class II 2008-01-04
K071554 VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM Volcano Corporation OBJ Class II 2008-01-04
K073094 VITALLINK3 MOBILE VITAL SIGNS SYSTEM Telemedic Systems, Ltd. MWI Class II 2008-01-04
K073113 INFINITY PICCO POD, MODEL MS16734 Draeger Medical Systems, Inc. DXG Class II 2008-01-03
K073378 ADVANCE 18LP PTA DILATATION CATHETER Cook, Inc. DQY Class II 2007-12-28
K072718 PENUMBRA SYSTEM Penumbra, Inc. NRY Class II 2007-12-28
K070357 FLEXCATH STEERABLE SHEATH & DILATOR Cryocath Technologies, Inc. DRA Class II 2007-12-28
K072886 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T Medrad, Inc. DXT Class II 2007-12-21
K073230 MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS Biotronik, Inc. DTA Class II 2007-12-20
K071885 ANTIMICROBIAL AND SINGLE-PATIENT CUFFS Philips Medical Systems OED Class II 2007-12-20
K072697 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES 3t Medical Systems, LLC DTN Class II 2007-12-20
K071818 ENSITE FUSION DYNAMIC REGISTRATION TOOL St Jude Medical DQK Class II 2007-12-20
K073397 MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) Microlife Corp. DXN Class II 2007-12-20
K073400 VARICATH PERIPHERAL INFUSION CATHETER Veinrx, Inc. KRA Class II 2007-12-20
K071730 STUDIODOP VICORDER Skidmore Medical, Limited JOP Class II 2007-12-20
K073398 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) Microlife Corp. DXN Class II 2007-12-20
K072810 PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010 Vascular Solutions, Inc. QEZ Class II 2007-12-19
K071691 DUAL SHOT ALPHA Nemoto Kyorindo Co., Ltd. DXT Class II 2007-12-19
K072796 MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 Concentric Medical, Inc. DQO Class II 2007-12-18
K071995 CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR Card Guard Scientific Survival , Ltd. DSI Class II 2007-12-18
K070060 WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) Welch Allyn, Inc. DXQ Class II 2007-12-18
K072552 MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE Merit Medical Systems, Inc. DQX Class II 2007-12-14
K070225 SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE Abiomed, Inc. DSP Class II 2007-12-13
K072765 PASSEO 18 Biotronik, Inc. LIT Class II 2007-12-12
K072513 DM-EMG Gvp Elettronica Srl DWJ Class II 2007-12-07
K072776 THE CROSSER SYSTEM Flowcardia, Inc. PDU Class II 2007-12-07
K072137 AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB Avita Corporation DXN Class II 2007-12-07
K071164 LIFE+CEL BATTERY Amco International Manufacturing & Design, Inc. MHX Class II 2007-12-07
K073372 ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) Systemsone DXJ Class II 2007-12-07
K072558 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 Cardionet, Inc. QYX Class II 2007-12-05
K072750 SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 Spectranetics Corp. DQY Class II 2007-12-04
K073147 SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 Transoma Medical MXC Class II 2007-12-03
K072325 BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 Jawon Medical Co., Ltd. MNW Class II 2007-11-30
K073100 INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S Oscor, Inc. DYB Class II 2007-11-30
K073203 CARESCAPE V100 Ge Medical Systems Information Technologies MHX Class II 2007-11-29
K072194 RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 Renu Medical, Inc. NLF Class II 2007-11-29
K073323 SA-3000P Medicore Co., Ltd. JOM Class II 2007-11-29
K072449 CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS Welch Allyn, Inc. DPS Class II 2007-11-29
K072049 CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS Bmeye B.V. DXN Class II 2007-11-29
K072346 PM-7000 PATIENT MONITOR Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MHX Class II 2007-11-29
K072446 MOBIL-O-GRAPH NG 24 H ABP-CONTROL I.E.M. GmbH DXN Class II 2007-11-29
K072372 PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE Mego Afek JOW Class II 2007-11-21
K072618 TWIN-PASS OTW CATHETER, MODEL 5201 Vascular Solutions, Inc. DQY Class II 2007-11-21
K071641 REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539) Medtronic, Inc. DSI Class II 2007-11-21
K071655 REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 Medtronic, Inc. DSI Class II 2007-11-21
K071228 FIDELITY 200 CARDIAC EVENT RECORDER Signalife, Inc. DXH Class II 2007-11-21
K073140 VITALOGIK MODEL 4000/4500 Mennen Medical , Ltd. DSI Class II 2007-11-21
K073146 PADNET+ Biomedix, Inc. JOM Class II 2007-11-21

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