meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2003-10-02

Clearances · page 89 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K032737 CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA Cordis Europa, N.V. DQY Class II 2003-10-02
K032587 EDWARDS PERIPHERAL DILATATION CATHETER Edwards Lifesciences, LLC DQY Class II 2003-10-02
K032695 HL888BF Health & Life Co., Ltd. DXN Class II 2003-10-02
K032913 HL888 AF Health & Life Co., Ltd. DXN Class II 2003-10-02
K031922 CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W Merit Medical Systems, Inc. DYB Class II 2003-10-01
K031652 VASCUPUNCTURE PICC GUIDEWIRE Neometrics, Inc. DQX Class II 2003-09-30
K031485 RINSPIRATION SYSTEM Kerberos Proximal Solutions DQO Class II 2003-09-25
K032591 NUMED TYSHAK MINI PEDIATRIC PTV CATHETER NuMED, Inc. DQY Class II 2003-09-25
K030187 REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical, Inc. NLH Class II 2003-09-24
K023429 ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620) Rowenta, Inc. MNW Class II 2003-09-23
K030966 CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER Boston Scientific Corp NAJ Class II 2003-09-23
K030145 GALIX WINTER Galix Biomedical Instrumentation, Inc. DQK Class II 2003-09-17
K032582 UNITY NETWORK PATIENT DATA SERVER Ge Medical Systems Information Technologies MSX Class II 2003-09-17
K032615 ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 Asahi Intecc Co., Ltd. DQX Class II 2003-09-16
K032749 BEDSIDE MONITOR, MODEL OPV-1500 Nihon Kohden America, Inc. MWI Class II 2003-09-16
K030504 AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 Idev Technologies, Inc. MCW Class II 2003-09-16
K031948 PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 Pm Devices, Inc. DXZ Class II 2003-09-16
K032569 SHORT INTRODUCER SHEATH Rex Medical DYB Class II 2003-09-16
K032404 SELDINGER SAFETY NEEDLE INTRODUCER Hdc Corp. DYB Class II 2003-09-10
K032624 MICRUS MICROCATHETER Micrus Corp. DQO Class II 2003-09-10
K030734 PATHWAY ACCESS SHEATH CATHETER Vertelink Corporation DYB Class II 2003-09-10
K031849 SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX Datascope Corp. MHX Class II 2003-09-09
K032492 BLOOD PRESSURE MONITOR, MODEL KP-7000 K-Jump Health Co., Ltd. DXN Class II 2003-09-09
K031970 INFINITY MEGACARE Siemens Medical Solutions USA, Inc. DQK Class II 2003-09-09
K031810 AMPLATZER VASCULAR PLUG Aga Medical Corp. KRD Class II 2003-09-09
K032589 ENCLOSE II ANASTOMOSIS ASSIST DEVICE Novare Surgical Systems, Inc. DXC Class II 2003-09-05
K032494 PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER Precision Vascular Systems, Inc. KRA Class II 2003-09-05
K032038 PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 Quinton, Inc. DQK Class II 2003-09-05
K031964 BPCARD Qrs Diagnostic, LLC DXN Class II 2003-09-05
K030629 DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER Dolphin Medical, Inc. DQA Class II 2003-09-04
K031785 MACROPORE CARDIO-WRAP (TS) Macropore Biosurgery, Inc. OMH Class II 2003-09-04
K032491 ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR Imagyn Medical Technologies, Inc. DSB Class II 2003-09-04
K030630 EDWARDS DIRECTIONAL CATHETER Edwards Lifesciences, LLC DQY Class II 2003-09-03
K031691 MERIT MAK (MINI ACCESS KIT) Merit Medical Systems, Inc. DRE Class II 2003-09-03
K032622 ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS Medtronic Vascular DQY Class II 2003-09-03
K032213 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP Stockert Instrumente GmbH DWA Class II 2003-08-29
K030742 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM Cryo Vascular Systems, Inc. LIT Class II 2003-08-29
K031700 MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 Medtronic Perfusion Systems DTN Class II 2003-08-29
K030898 MOBILE BATTERY SERVICE STATION (MBSS) Ad Elektronik GmbH MKJ Class III 2003-08-27
K032276 CLICK HOLTER Remco Italia S.P.A. MWJ Class II 2003-08-27
K031187 HEARTSTART MRX, MODEL M3535A Philips Medical Systems MKJ Class III 2003-08-27
K032069 WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER AngioDynamics, Inc. DQY Class II 2003-08-27
K032041 DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) LeMaitre Vascular, Inc. DWF Class II 2003-08-27
K032376 ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER AngioDynamics, Inc. DQO Class II 2003-08-26
K032250 GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 Edwards Lifesciences, LLC KRH Class II 2003-08-26
K031678 HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Guidant Corp. DQX Class II 2003-08-26
K031740 VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES Welch Allyn Protocol, Inc. DQA Class II 2003-08-26
K032298 MODIFICATION TO OUTBACK CATHETER Lumend, Inc. DQY Class II 2003-08-26
K032466 SPIDERVIEW Ela Medical, Inc. MWJ Class II 2003-08-22
K031692 SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 Intra Luminal Therapeutics, Inc. DQY Class II 2003-08-22
K032068 CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 Cardiovention, Inc. DTR Class II 2003-08-22
K032261 Trellis Reserve Infusion System Bacchus Vascular, Inc. QEY Class II 2003-08-22
K030357 QUANTIX/OR DEVICE Cardiosonix, Ltd. DPW Class II 2003-08-20
K032225 EP-WORKMATE WITH RPM SYSTEM Ep Medsystems DQK Class II 2003-08-20
K031433 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS Siemens Medical Solutions USA, Inc. DSI Class II 2003-08-19
K030222 NX SYSTEM American Telecare, Inc. DRG Class II 2003-08-19
K031742 BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER Bci, Inc. DQA Class II 2003-08-18
K032369 MODIFICATION TO: APEXPRO TELEMETRY SYSTEM Ge Medical Systems Information Technologies MHX Class II 2003-08-15
K032073 GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE W. L. Gore & Associates, Inc. DYB Class II 2003-08-13
K032370 CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION Ge Medical Systems Information Technologies DSI Class II 2003-08-13
K031442 PBN GUIDEWIRES Medical Device Technologies, Inc. DQX Class II 2003-08-13
K032146 PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES Precision Vascular Systems, Inc. DQX Class II 2003-08-12
K031636 CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX Datascope Corp. DSP Class II 2003-08-11
K032050 PERIVAC KIT Boston Scientific Corp DQX Class II 2003-08-08
K030109 ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp. NLH Class II 2003-08-08
K032142 DATACAPTOR Capsule Technologie MWI Class II 2003-08-08
K031544 HEATER COOLER UNIT, MODEL HCU 30 Jostra AB DWC Class II 2003-08-07
K031992 ECHELON MICRO CATHETER, MODEL 105-5091 Micro Therapeutics, Inc. KRA Class II 2003-08-07
K030316 AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) Inovise Medical, Inc. DRX Class II 2003-08-07
K031586 CORRESTORE PATCH SYSTEM Somanetics Corp. DXZ Class II 2003-08-07
K031706 CARDIOQ, MODEL 9051-7005 Deltex Medical DPW Class II 2003-08-06
K032346 UNITY NETWORK IS PATIENT VIEWER Ge Medical Systems Information Technologies MSX Class II 2003-08-05
K030795 LIFESYNE SYSTEMS Gmp/Companies, Inc. DRG Class II 2003-08-05
K023548 PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 Velocimed DQY Class II 2003-08-04
K031323 DBT, DYNAMIC BUBBLE TRAP Convergenza AG DTM Class II 2003-08-01
K032183 IQ HYDROPHILIC GUIDE WIRE Boston Scientific Corp DQX Class II 2003-08-01
K024283 CARDIODIRECT, MODELS 12M, 12I, 12S Reynolds Medical , Ltd. DPS Class II 2003-08-01
K032128 TERUMO AL8X ARTERIAL FILTER WITH X-COATING Terumo Cardiovascular Systems Corp. DTM Class II 2003-08-01
K014241 COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D Alsius Corp. NCX Class II 2003-08-01
K012715 HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II Hygia Health Services, Inc. NLF Class II 2003-08-01
K031561 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM Ge Medical Systems Information Technologies DQK Class II 2003-08-01
K031582 WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 Nihon Seimitsu Sokki Co., Ltd. MNW Class II 2003-08-01
K031483 MEDRAD MANUAL SYRINGE LOADER Medrad, Inc. DXT Class II 2003-08-01
K030671 MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB Medtronic Vascular DQY Class II 2003-07-31
K031987 POWERHEART AED G3, MODEL 9300 Cardiac Science MKJ Class III 2003-07-30
K031550 REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE Vivometrics, Inc. DQK Class II 2003-07-29
K031182 ELI 200+ AUDICOR Mortara Instrument, Inc. DPS Class II 2003-07-25
K030221 MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR Mytech Technology Co., Ltd. DXN Class II 2003-07-25
K031328 RECOVERY FILTER SYSTEM, MODEL RF-048F C.R. Bard, Inc. DTK Class II 2003-07-25
K031776 MC2X MULTI-STAGE VENOUS CANNULA Medtronic Perfusion Systems DWF Class II 2003-07-25
K031459 RAPIDO CUT-AWAY CUTTER Guidant Corp. DQY Class II 2003-07-23
K023044 MODEL 9600, AVANT PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2003-07-23
K030973 PICOSAT II SPO2 PULSE OXIMETRY MODULE Philips Medical Systems DQA Class II 2003-07-23
K030637 EKOS PERIPHERAL INFUSION SYSTEM Ekos Corp. QEY Class II 2003-07-22
K031161 VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER Biosense Webster, Inc. DRF Class II 2003-07-22
K032103 PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A Philips Medical Systems DSH Class II 2003-07-22
K031906 APEEL CS CATHETER DELIVERY SYSTEM St Jude Medical DYB Class II 2003-07-18
K032129 RADIUS 018 COUGAR WIRE Radius Medical Technologies, Inc. DQX Class II 2003-07-17
K031211 ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH Medtronic Vascular DQY Class II 2003-07-17
K031916 GALT MEDICAL GUIDEWIRE Galt Medical Corp. DQX Class II 2003-07-17

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