meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
2004-06-18

Clearances · page 86 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040728 ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT AngioDynamics, Inc. DYB Class II 2004-06-18
K040830 PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NuMED, Inc. DQO Class II 2004-06-18
K040730 VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP Vascular Solutions, Inc. DXC Class II 2004-06-18
K033896 DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P Defibtech, LLC MKJ Class III 2004-06-16
K041306 NUMED PTS X SIZING BALLOON CATHETER NuMED, Inc. MJN Class II 2004-06-10
K040753 R-TEST EVOLUTION 3 Novacor MLO Class II 2004-06-10
K041156 AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 Nonin Medical, Inc. DQA Class II 2004-06-09
K040969 POISE DATAENGINE Poise Technology Corporation MWI Class II 2004-06-08
K041281 DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES Datascope Corp. DSP Class II 2004-06-07
K041180 QUANTIX OR VESSEL STABILIZER DEVICE Cardiosonix, Ltd. DPW Class II 2004-06-07
K041235 PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH MHX Class II 2004-06-04
K041401 MODIFICATION TO M2376A DEVICELINK SYSTEM Philips Medical Systems MWI Class II 2004-06-04
K040559 MODIFICATION TO UNITY NETWORK ID Ge Medical Systems Information Technologies MWI Class II 2004-06-04
K040654 SENSILASE PAD 3000 Optical Sensors, Inc. DPW Class II 2004-06-04
K040458 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR Ge Medical Systems Information Technologies MHX Class II 2004-06-03
K040589 MODIFICATION TO AVANT 9600 PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2004-06-03
K033711 FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM Fukuda Denshi USA, Inc. MHX Class II 2004-06-03
K041134 COMBOMAP PRESSURE AND FLOW SYSTEM Volcano Therapeutics, Inc. OBJ Class II 2004-06-02
K040966 MODIFICATION TO CAREMATIX WELLNESS SYSTEM Carematix, Inc. DRG Class II 2004-06-02
K040615 COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM Advanced Vascular Dynamics DXC Class II 2004-06-01
K040713 MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM Thomas Medical Products, Inc. DYB Class II 2004-06-01
K033048 CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS Cas Medical Systems, Inc. MHX Class II 2004-06-01
K040869 EXPORT CATHETER Medtronic Vascular QEZ Class II 2004-06-01
K040395 CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES Nihon Kohden America, Inc. MHX Class II 2004-06-01
K040552 MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 Cryocor, Inc. DYB Class II 2004-05-28
K040581 MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM Vitel Net DQA Class II 2004-05-27
K040246 FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. MHX Class II 2004-05-26
K031517 ZARGIS ACOUSTIC CARDIOSCAN Zargis Medical Corp. DQD Class II 2004-05-26
K041067 HEARTSINE SAMARITAN PAD Heartsine Technologies, Inc. MKJ Class III 2004-05-25
K033642 SMARTLANK WIRELESS, MODEL 001970 Mrl, A Welch Allyn Company MKJ Class III 2004-05-25
K033540 TRANSXCHANGE SUPPORT CATHETER Medtronic Vascular DQY Class II 2004-05-25
K032977 JMS BYPASS TUBE Jms North America Corp. DWF Class II 2004-05-25
K041291 RINSPIRATION SYSTEM Kerberos Proximal Solutions, Inc. DQO Class II 2004-05-21
K032755 MODEL 509M PULSE OXIMETER, MODEL 509M Respironics Novametrix, Inc. DQA Class II 2004-05-21
K033474 ZOLL AED PLUS Zoll Medical Corp MKJ Class III 2004-05-21
K033623 CELSIUS CONTROL SYSTEM Innercool Therapies, Inc. NCX Class II 2004-05-21
K040829 GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR Vascutek, Ltd. DSY Class II 2004-05-20
K040371 A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 2004-05-19
K031357 GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM Possis Medical, Inc. MJN Class II 2004-05-18
K040013 ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT Possis Medical, Inc. QEZ Class II 2004-05-18
K041228 MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 Mytech Technology Co., Ltd. DXN Class II 2004-05-17
K040825 LAKE REGION HYDROPHILIC GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2004-05-17
K033957 INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL Draeger Medical Systems, Inc. MHX Class II 2004-05-14
K024215 ENERTRON CPR JACK Enertron Engineering Co. DRM Class II 2004-05-14
K041087 INFINITY GAMMA Draeger Medical Systems, Inc. MHX Class II 2004-05-12
K031327 VERICOR Cvp Diagnostics, Inc. DXN Class II 2004-05-12
K040165 REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 St Jude Medical DRA Class II 2004-05-12
K040955 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN Philips Medical Systems, Inc. MHX Class II 2004-05-12
K040945 MODIFICATION TO INFINITY EXPLORER Draeger Medical Systems, Inc. MSX Class II 2004-05-12
K040954 FOX PLUS PTA CATHETER Abbott Laboratories, Inc. LIT Class II 2004-05-11
K032927 FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR Sein Electronics Co., Ltd. DXN Class II 2004-05-07
K041093 NUMED MULLINS X PTA CATHETER NuMED, Inc. DQY Class II 2004-05-06
K041061 D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS Dideco S.P.A. DTM Class II 2004-05-06
K040801 INTRA-AORTIC BALLOON (IAB) Arrow Intl., Inc. DSP Class II 2004-05-06
K033307 NVISION DATA MANAGEMENT SOFTWARE Nonin Medical, Inc. DQA Class II 2004-05-06
K040410 GREENLIGHT 300 A C Cossor & Son (Surgical) Limited DXN Class II 2004-05-05
K033670 GORE TRI-LOBE BALLOON CATHETER W. L. Gore & Associates, Inc. DQY Class II 2004-05-05
K033216 BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR The Buzz Group, LLC DXN Class II 2004-05-04
K040404 HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Inc. MKJ Class III 2004-05-04
K040867 PERIVAC KIT, MODELS 4304, 4305, 4314, 4315 Boston Scientific Corp DQX Class II 2004-04-30
K040228 MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 Medi-Stim A/S DPW Class II 2004-04-29
K040776 ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 Boston Scientific Corp DQO Class II 2004-04-29
K032568 BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 Med Textile, LLC DXQ Class II 2004-04-29
K040632 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 Smiths Medical Asd, Inc. DWJ Class II 2004-04-27
K033085 PORTACLAMP Cardio Life Research, S.A. DXC Class II 2004-04-27
K040067 CLIRPATH EXCIMER LASER CATHETER Spectranetics Corp. PDU Class II 2004-04-27
K040440 HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) Http Hypothermia Therapy DWJ Class II 2004-04-27
K040287 VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR Edwards Lifesciences, LLC DXG Class II 2004-04-26
K040775 LIFEPAK 12 Medtronic Physio-Control Corp. MKJ Class III 2004-04-23
K040771 MODIFICATION TO OUTBACK CATHETER Lumend, Inc. DQY Class II 2004-04-23
K040259 MASIMO SET INTELLIVUE PULSE OXIMETER MODULE Masimo Corp. DQA Class II 2004-04-22
K040909 SONO TT ULTRASONIC FLOWCOMPUTER Em-Tec GmbH DPW Class II 2004-04-20
K040786 VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING Neometrics, Inc. DQX Class II 2004-04-19
K033963 EP DEFLECTABLE CATHETERS Ep Medsystems, Inc. DRF Class II 2004-04-15
K040528 AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T Ya Horng Electronic Co., Ltd. DXN Class II 2004-04-15
K031557 CARDIOVIT AT-102 Schiller AG DPS Class II 2004-04-14
K040415 PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT Synovis Surgical Innovations DXZ Class II 2004-04-14
K040342 INTERLOCKING DETACHABLE COIL SYSTEM (IDC) Boston Scientific Corp KRD Class II 2004-04-13
K033133 TELECARE D.R. SERVER SOFTWARE SYSTEM Healthcare Vision, Inc. MWI Class II 2004-04-13
K040256 PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 Bio-Detek, Inc. MKJ Class III 2004-04-09
K033397 AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY Avita Corporation DXN Class II 2004-04-09
K040056 BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 Bio-Detek, Inc. MKJ Class III 2004-04-09
K033157 TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 Tanita Corp. of America MNW Class II 2004-04-08
K040569 PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU Oscor, Inc. DTB Class III 2004-04-07
K040784 PROTAB ECG TABB ELECTRODE Bio Protech, Inc. DRX Class II 2004-04-07
K040313 HRV TOOLS Del Mar Reynolds Medical, Ltd. DPS Class II 2004-04-06
K040029 SAFETYNET GUIDEWIRE INTRODUCER Injectimed, Inc. DYB Class II 2004-04-05
K040012 WELL@HOME SYSTEM Zoe Medical, Inc. DXN Class II 2004-04-02
K033875 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. DQY Class II 2004-04-02
K040065 JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES Jack Speer and Assoc., Inc. JOW Class II 2004-03-29
K034025 NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC Nmt Medical, Inc. DYB Class II 2004-03-26
K034068 CONTOUR SE MICROSPHERES Boston Scientific Corp KRD Class II 2004-03-26
K033050 EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 Medtronic Vascular DRF Class II 2004-03-26
K024213 SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 Siemens Medical Solutions USA, Inc. DSI Class II 2004-03-23
K033694 INFINITY MODULAR MONITORS VF4 MODIFICATIONS Draeger Medical Systems, Inc. MHX Class II 2004-03-22
K031487 MODEL AVANT 2120 PULSE OXIMETER AND NIBP Nonin Medical, Inc. DXN Class II 2004-03-22
K034050 CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F Cordis Corporation DTK Class II 2004-03-22
K040002 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 Microlife Intellectual Property Gmb DXN Class II 2004-03-22
K040159 APM BLOOD PRESSURE MONITOR, MODEL BP108A Asia Pacific Microsystems, Inc. DXN Class II 2004-03-22
K040173 PEDIATRIC AORTIC ROOT CANNULA Medtronic Perfusion Systems DWF Class II 2004-03-19

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