meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
2002-10-11

Clearances · page 93 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K020964 NEICH NM ADVANCE CATHETER SHEATH INTRODUCER Neich Medical(Shenzhen)Company, Ltd. DYB Class II 2002-10-11
K022280 STOCKERT CORONARY PERFUSION CANNULAE Stockert Instrumente GmbH DWF Class II 2002-10-11
K022316 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2002-10-10
K022321 STOCKERT V172-28 VENOUS FEMORAL CANNULA Stockert Instrumente GmbH DWF Class II 2002-10-09
K022238 MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 Medtronic Vascular DWS Class I 2002-10-09
K021955 TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES Datex-Ohmeda, Inc. DQA Class II 2002-10-08
K022210 MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 Cardiac Science, Inc. MKJ Class III 2002-10-04
K012344 VANGUARD REPROCESSED PULSE OXIMETER SENSORS Vanguard Medical Concepts, Inc. NLF Class II 2002-10-04
K022257 VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX Vomed Volzer Medizintechnik GmbH & Co. DRC Class II 2002-10-04
K022939 OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES Osypka Medical, Inc. DTE Class II 2002-10-03
K022188 RADIANALYZER, MODEL 12710 Radi Medical Systems AB DQK Class II 2002-10-03
K022485 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE Datex-Ohmeda MHX Class II 2002-10-03
K011208 BIOVER Biover AG DXC Class II 2002-10-02
K022380 LIVESIRE ELECTROPHYSIOLOGY CATHETER St Jude Medical DRF Class II 2002-10-01
K022298 I-STETHOS LINK Andromed, Inc. DQD Class II 2002-10-01
K021495 QIVA Pie Medical Imaging BV DQK Class II 2002-10-01
K021454 UNITY NETWORK ID General Electric Medical Systems Information Techn MWI Class II 2002-10-01
K021389 BIOLOGICAL SOUND MONITOR (BSM) SENSOR Andromed, Inc. DQD Class II 2002-10-01
K022552 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. DQY Class II 2002-09-27
K022115 CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR Terumo Corp. DTZ Class II 2002-09-27
K022297 GLOBAL ECG MANAGEMENT SYSTEM (GEMS) Cardiocomm Solutions, Inc. DSH Class II 2002-09-27
K022084 ATLAS MONITOR, MODELS 200,210,220 Welch Allyn, Inc. DQA Class II 2002-09-26
K023015 CARDIS Schwarzer GmbH DQK Class II 2002-09-25
K022889 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER Siemens Medical Solutions USA, Inc. MHX Class II 2002-09-25
K022187 PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 Radi Medical Systems AB DXO Class II 2002-09-24
K022819 NELLCOR N-200 PULSE OXIMETER, MODEL N-200 Nellcor Puritan Bennett, Inc. DQA Class II 2002-09-24
K022138 SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 Spectranetics Corp. DQY Class II 2002-09-23
K020571 STOCKERT CENTRIFUGAL PUMP CONSOLE Stockert Instrumente GmbH DTQ Class II 2002-09-23
K022093 CHASE CARDIOVASCULAR PATCH KIT Chase Medical, Inc. DXZ Class II 2002-09-20
K022061 CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER Cryo Vascular Systems, Inc. DQY Class II 2002-09-20
K022786 DVT60 Huntleigh Healthcare, Inc. JOW Class II 2002-09-19
K022075 DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 Cp Medical DSA Class II 2002-09-19
K022363 SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) St. Jude Medical, Inc. KRH Class II 2002-09-19
K022857 PUMP TUBING WITH X-COATING Terumo Cardiovascular Systems Corporation DWE Class II 2002-09-19
K022163 WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 Welch Allyn, Inc. DQA Class II 2002-09-17
K022920 M2376A DEVICELINK SYSTEM Philips Medical Systems MWI Class II 2002-09-17
K022003 TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 Micro Therapeutics, Inc. DYB Class II 2002-09-13
K022722 PTA AND PTV NuMED, Inc. DQY Class II 2002-09-13
K022537 PRESS-MATE PM-2100 VITAL SIGN MONITOR Colin Medical Instruments Corp. MWI Class II 2002-09-13
K022738 AGILTRAC .035 PERIPHERAL DILATATION CATHETER Guidant Corp. DQY Class II 2002-09-13
K014141 DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 Digibio Technology Corp. DXN Class II 2002-09-13
K022880 GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 Guidant Corp. DXC Class II 2002-09-13
K022022 JOSTRA VENT CATHETERS, MODELS LV & HKV Jostra AG DWF Class II 2002-09-11
K022677 MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE Alaris Medical Systems, Inc. DQA Class II 2002-09-11
K022618 X-SCRIBE II Mortara Instrument, Inc. DPS Class II 2002-09-06
K022766 SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER Siemens Medical Solutions USA, Inc. DQA Class II 2002-09-05
K020693 AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 Embol-X, Inc. DWF Class II 2002-09-05
K021906 QUINTON Q-CATH, MODEL 000460 Quinton, Inc. DQK Class II 2002-09-04
K022621 BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER Boston Scientific Corp DQO Class II 2002-09-04
K022042 MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) Cardeon Corp. DWF Class II 2002-09-03
K022764 7F LAUNCHER GUIDE CATHETER Medtronic Vascular DQY Class II 2002-08-28
K020550 PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX Datascope Corp. DSI Class II 2002-08-28
K020529 LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 A-Med Systems, Inc. KFM Class II 2002-08-26
K021996 BOLTON PTA CATHETER Bolton Medical, Inc. LIT Class II 2002-08-23
K022689 MODIFICATION TO MEDAMICUS AXIA RSN Medamicus, Inc. DYB Class II 2002-08-23
K022507 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 Datex-Ohmeda MSX Class II 2002-08-23
K020768 3T VESSEL CANNULAS 3t Medical Systems, LLC DWF Class II 2002-08-23
K013046 COSMOS SYSTEM Spacelabs Medical, Inc. DSI Class II 2002-08-21
K021528 REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP Adven Medical JOW Class II 2002-08-21
K022453 MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM Welch Allyn Protocol, Inc. DSI Class II 2002-08-21
K014210 PALMO THERMOREGULATION INTERFACE ACCESSORY Avacore Technologies, Inc. DWJ Class II 2002-08-16
K020537 TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM Tensys Medical, Inc. DXN Class II 2002-08-15
K022345 AUTOPULSE RESUSCITATION SYSTEM Revivant Corp. DRM Class II 2002-08-15
K020984 ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS Access Cardiosystems, Inc. MKJ Class III 2002-08-14
K020290 DASH 3000/4000 PATIENT MONITOR General Electric Medical Systems Information Techn MHX Class II 2002-08-14
K022435 507EL VITAL SIGNS MONITOR Criticare Systems, Inc. DRT Class II 2002-08-14
K012678 REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. NLH Class II 2002-08-14
K012523 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. NLH Class II 2002-08-14
K013038 SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 Polystan A/S DTZ Class II 2002-08-14
K022242 INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER Intervascular DSY Class II 2002-08-14
K022482 SENSA-CUFF, MODELS INFANT, CHILD, ADULT Ge Medical Systems Information Technologies DXQ Class II 2002-08-13
K012708 ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp. NLH Class II 2002-08-13
K010727 FLEXLINE CLAMP Novare Surgical Systems, Inc. DXC Class II 2002-08-09
K021735 BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER Boston Scientific Scimed, Inc. DQY Class II 2002-08-08
K022107 CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 Cardiomedics, Inc. DRN Class II 2002-08-08
K021723 SHEATH ADAPTER, MODEL SA-09847 Arrow Intl., Inc. DYB Class II 2002-08-08
K022281 SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 Polystan A/S DTN Class II 2002-08-06
K020897 ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400 Rossmax Internationl , Ltd. DXN Class II 2002-08-06
K021455 RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, Guidant Corp. DQY Class II 2002-08-02
K022168 ENVOY Mennen Medical , Ltd. DQA Class II 2002-08-01
K022193 DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N Ge Medical Systems Information Technologies DQA Class II 2002-08-01
K012687 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2002-08-01
K012688 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2002-07-31
K022174 MODIFICATION TO CARDEON AEGIS CATHETER Cardeon Corp. DWF Class II 2002-07-29
K021641 XTD THROMBECTOMY CATHETER, XX CM Xtrak Medical, Inc. QEW Class II 2002-07-26
K021638 ILT ADVANCING MECHANISM, MODEL A115AMI Intra Luminal Therapeutics, Inc. DQX Class II 2002-07-26
K022116 ELPH INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business DXT Class II 2002-07-26
K021376 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE Datex-Ohmeda DSI Class II 2002-07-24
K021517 ABP FOR WINDOWS Rozinn Electronics, Inc. DSK Class II 2002-07-24
K022073 HEARTLINE RECEIVING STATION Aerotel Medical Systems (1998) , Ltd. DXH Class II 2002-07-24
K021681 MICROPAQ, MODELS 402, 404 Welch Allyn Protocol, Inc. DRT Class II 2002-07-23
K012770 INFINITY MICRO2+ Siemens Medical Solutions USA, Inc. DQA Class II 2002-07-23
K021279 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE Datex-Ohmeda MHX Class II 2002-07-19
K012574 REPROCESSED FEMORAL COMPRESSION DEVICE Sterilmed, Inc. NMF Class II 2002-07-18
K021990 GALT MEDICAL GUIDEWIRE Galt Medical Corp. DQX Class II 2002-07-18
K021778 PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B Philips Medical Systems DQA Class II 2002-07-17
K022152 HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS Cambridge Heart, Inc. DPS Class II 2002-07-16
K022149 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 Cambridge Heart, Inc. DPS Class II 2002-07-16
K021874 ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 Abbott Laboratories DXG Class II 2002-07-12
K021959 DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 Dolphin Medical, Inc. DQA Class II 2002-07-11

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