meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
2003-07-16

Clearances · page 90 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K031376 DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES Ge Medical Systems Information Technologies MHX Class II 2003-07-16
K031416 CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF Clearmedical, Inc. DXQ Class II 2003-07-15
K030135 SAFETY INTRODUCER NEEDLE B.Braun Medical, Inc. DYB Class II 2003-07-15
K030788 KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS Geister Medizin Technik GmbH DWP Class II 2003-07-12
K031339 OPTIBOLUS Mallinckrodt Inc., Liebel-Flarsheim Business DXT Class II 2003-07-11
K030547 MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE Guardian Angel Products, Inc. DRL Class II 2003-07-11
K031417 ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 Intra Luminal Therapeutics, Inc. DQY Class II 2003-07-11
K030852 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX Mogul Enterprises DRF Class II 2003-07-10
K031174 BODY SIGNAL ECG ELECTRODE Wandy Rubber Industrial Co., Ltd. DRX Class II 2003-07-10
K032040 IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR Dideco S.P.A. KFM Class II 2003-07-09
K031229 TELZUIT CARDIAC MONITORING SYSTEM Telzuit Technologies, Inc. DXH Class II 2003-07-09
K031422 PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 Philips Medical Systems DPS Class II 2003-07-03
K031827 ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX Medtronic Perfusion Systems DWF Class II 2003-07-02
K031688 RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE Guidant Corporation DTL Class II 2003-07-02
K031695 HL168R Health & Life Co., Ltd. DXN Class II 2003-07-01
K031835 HL888RA Health & Life Co., Ltd. DXN Class II 2003-07-01
K024323 CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 Biomedical Systems Corp. MLO Class II 2003-06-30
K024000 METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER Angiometrx, Inc. DQO Class II 2003-06-26
K031766 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. DQY Class II 2003-06-26
K031151 TS3 TUBING SET Global Blood Resources, LLC DWF Class II 2003-06-26
K031781 DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES Datex-Ohmeda MHX Class II 2003-06-25
K023817 SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 Clio Designs, Inc. MNW Class II 2003-06-25
K031505 RAPIDO CUT-AWAY GUIDING CATHETER Guidant Corporation DQY Class II 2003-06-25
K031864 NITREX NITINOL GUIDEWIRE Ev3 Corporation DQX Class II 2003-06-24
K031346 JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 Jomed, Inc. OBJ Class II 2003-06-23
K031150 HEMOBAG, MODEL HBBSD2000 Global Blood Resources, LLC DTN Class II 2003-06-23
K030218 PER, MODEL MEMO Medical Monitors Pty., Ltd. DXH Class II 2003-06-23
K030944 EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL Edwards Lifesciences, LLC DYB Class II 2003-06-20
K024243 REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 Fox Hollow Technologies MCW Class II 2003-06-20
K031571 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 E-Z-Em, Inc. IZQ Class II 2003-06-19
K031164 PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV Oscor, Inc. DTD Class II 2003-06-19
K031005 LUMEND FRONTRUNNER GW CTO CATHETER Lumend, Inc. PDU Class II 2003-06-18
K023591 ULTRA HIGH PRESSURE INJECTOR LINES Deroyal Industries, Inc. DQO Class II 2003-06-18
K031583 MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 Integrated Vascular Systems, Inc. DYB Class II 2003-06-16
K023174 DISPOSABLE TEMPORARY PACING WIRE River Medical, Inc. LDF Class II 2003-06-11
K030535 EKGCARD SYSTEM Qrs Diagnostic, LLC DPS Class II 2003-06-11
K030104 PRIME ECG SYSTEM Meridian Medical Technologies, Inc. DPS Class II 2003-06-11
K031466 IQMARK DIGITAL HOLTER Brentwood Medical Technology Corp. MLO Class II 2003-06-11
K023080 GALIX PACESTAR Galix Biomedical Instrumentation, Inc. DTE Class II 2003-06-11
K031569 DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX Datascope Corp. DSP Class II 2003-06-10
K022926 GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100 Genteel Technology Co., Ltd. DXN Class II 2003-06-06
K031662 PRESSURE WIRE SENSOR, MODELS 12004/12304 Radi Medical Systems AB DXO Class II 2003-06-06
K031479 AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 Datex-Ohmeda, Inc. DXN Class II 2003-06-06
K030738 SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM Siemens Medical Solutions USA, Inc. MHX Class II 2003-06-06
K023691 BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC Boston Scientific Epi NFA Class II 2003-06-04
K023940 SHELHIGH BIORING Shelhigh, Inc. KRH Class II 2003-06-04
K031000 LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 C.R. Bard, Inc. DQK Class II 2003-06-03
K024019 ARTERIALFLOW SYSTEM, MODEL 32A Aircast, Inc. JOW Class II 2003-06-03
K023195 MAGLIFE C/MAGLIFE C PLUS Schiller Medical S.A. MWI Class II 2003-06-03
K030640 SIEMENS MICRO2+ WITH VAI SOFTWARE Siemens Medical Solutions USA, Inc. DQA Class II 2003-06-03
K031403 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 Philips Medical Systems, Inc. MHX Class II 2003-05-30
K030587 EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP S-Tct Health, Inc. DRN Class II 2003-05-30
K030726 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING Gish Biomedical, Inc. DTN Class II 2003-05-30
K024278 PACEART SYSTEM Medtronic Vascular DPS Class II 2003-05-29
K022274 CARECOMPANION PATIENT STATION & NURSE STATION Neptec Design Group, Ltd. DRG Class II 2003-05-29
K031481 THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 Philips Medizin Systeme Boblingen GmbH MHX Class II 2003-05-29
K031148 IN-VISION IMAGING SYSTEM Jomed, Inc. DXK Class II 2003-05-28
K031610 REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical MCW Class II 2003-05-27
K023937 COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM Cook Vascular, Inc. DYB Class II 2003-05-27
K030230 AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) Avita Corporation DXN Class II 2003-05-23
K030930 OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N Nellcor Puritan Bennett, Inc. DQA Class II 2003-05-23
K030398 CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 Cardiacassist, Inc. DQR Class II 2003-05-23
K031274 MODEL 5071 MYOCARDIAL PACING LEAD Medtronic Vascular DTB Class III 2003-05-22
K020738 AVITA BF1 (VITALIO) BODY FAT ANALYZER Avita Corporation MNW Class II 2003-05-22
K031518 EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, Medtronic Vascular DWF Class II 2003-05-22
K030589 MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS NuMED, Inc. DQY Class II 2003-05-21
K030617 PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE Boston Scientific Scimed, Inc. DQX Class II 2003-05-21
K030812 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE Datex-Ohmeda MHX Class II 2003-05-21
K031398 IS-1 HEMOSTASIS VALVE, MODEL 6799 Guidant Corp. DTL Class II 2003-05-20
K030952 DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 Dolphin Medical, Inc. DQA Class II 2003-05-19
K031210 MODEL 4951M MYOCARDIAL UNIPOLAR LEAD Metronic, Inc. DTB Class III 2003-05-16
K031300 IBC FLOPUMP WITH GBS COATING Gish Biomedical, Inc. KFM Class II 2003-05-14
K030505 CAPIOX CARDIOTOMY RESERVOIR Terumo Cardiovascular Systems Corp. DPW Class II 2003-05-14
K030549 HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG Guidcorp DQX Class II 2003-05-14
K031277 JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 Jomed, Inc. DQX Class II 2003-05-14
K022834 DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 Ge Medical Systems Information Technologies MHX Class II 2003-05-13
K031037 EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE Medtronic Perfusion Systems DWF Class II 2003-05-13
K023478 INBODY AP1 BODY COMPOSITION ANALYZER Biospace Co.,Ltd MNW Class II 2003-05-13
K031330 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2003-05-12
K030931 C3 PATIENT MONITOR Analogic Corp. MHX Class II 2003-05-09
K021230 HERO Medical Decision Networks DPS Class II 2003-05-09
K030561 MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A Mytech Technology Co., Ltd. DXN Class II 2003-05-09
K030417 DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES Philips Medical Systems LDD Class II 2003-05-09
K023338 PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 Fms, Finapres Medical Systems BV DXN Class II 2003-05-09
K023759 CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER Sonomedica DQD Class II 2003-05-06
K031320 EK-PRO ARRHYTHMIA DETECTION ALGORITHM Ge Medical Systems Information Technologies MHX Class II 2003-05-06
K030349 HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 Bonso Electronics International, Inc. MNW Class II 2003-05-02
K031223 SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR Dideco S.P.A. DTZ Class II 2003-05-02
K023286 CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION Neptec Design Group, Ltd. DXN Class II 2003-05-02
K030026 REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp. NLH Class II 2003-05-02
K020925 CARBODISSECTING ENDOSCOPE Endo Surgical Devices, Inc. DWX Class II 2003-04-29
K021174 ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR Imagyn Surgical DSB Class II 2003-04-29
K031087 EDWARDS INTRODUCER SHEATH Edwards Lifesciences, LLC DYB Class II 2003-04-24
K030541 HL888JF Health & Life Co., Ltd. DXN Class II 2003-04-24
K030984 SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT Intra Luminal Therapeutics, Inc. DQY Class II 2003-04-24
K030779 5F MEDTRONIC LAUNCHER GUIDE CATHETER Medtronic Vascular DQY Class II 2003-04-24
K023205 ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP Biotronik, Inc. DTB Class III 2003-04-24
K030715 SAFFRON NM GUIDING CATHETER Neich Medical (Shenzhen) Company Limited DQY Class II 2003-04-24
K031091 VTI 20 MHZ GATED DOPPLER Vascular Technology Incorporated DPW Class II 2003-04-23
K030129 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. DQK Class II 2003-04-22

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