Product Code: OBJ


Products Classified as OBJ

925Catheter, Ultrasound, IntravascularDiagnostic Intravascular Catheter.

Total Product Life Cycle (TPLC) Devices

925Catheter, Ultrasound, IntravascularDiagnostic Intravascular Catheter.

FDA Consensus Standards

Catheter, Ultrasound, Intravascular [32412]21 CFR §870.1200 🔎

Pre-market Notifications for OBJ

K223077ViewFlex Xtra ICE CatheterIrvine Biomedical, A St. Jude Medical Company
K222568OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation
K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation
K212959ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterSiemens Medical Solutions USA, Inc.
K201775NuVision ICE CatheterNuVera Medical, Inc.
K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterPhilips Image Guided Therapy Corporation
K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation
K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc.
K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterACIST Medical Systems, Inc.
K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemACIST Medical Systems, Inc.
K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation
K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc.
K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation
K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemACIST Medical Systems, Inc.
K172258Novasight Hybrid SystemConavi Medical Inc.

Global Unique Device Identification Database

30801902111471Catheter, ultrasound, intravascular
30801902111464Catheter, ultrasound, intravascular
00801902091871Catheter, ultrasound, intravascular
30801902091858Catheter, ultrasound, intravascular
30801902089831Catheter, ultrasound, intravascular
00801902078407Catheter, ultrasound, intravascular
00184360000709Catheter, Ultrasound, Intravascular
00184360000358Catheter, Ultrasound, Intravascular
00084522501874Catheter, Ultrasound, Intravascular
00857595006418Catheter, Ultrasound, Intravascular
00857595006401Catheter, Ultrasound, Intravascular
00857595006210Catheter, Ultrasound, Intravascular
00845225012755Catheter, Ultrasound, Intravascular
00845225012588Catheter, Ultrasound, Intravascular
00845225012304Catheter, Ultrasound, Intravascular

Maude Adverse Events

OPTICROSS HDBOSTON SCIENTIFIC CORPORATION2020-03-31
OPTICROSS 18BOSTON SCIENTIFIC CORPORATION2020-03-30
VISIONS PV .035 DIGITAL IVUS CATHETERVOLCARICA S.R.L.2020-03-27
VISIONS PV .035 DIGITAL IVUS CATHETERPHILIPS VOLCANO2020-03-26
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-24
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-20
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-20
VIEWFLEX?ICE CATHETERST. JUDE MEDICAL, INC.2020-03-20
VIEWFLEX? XTRA ICE CATHETERST. JUDE MEDICAL, INC.2020-03-19
OPTICROSS 18BOSTON SCIENTIFIC CORPORATION2020-03-19
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-19
SOUNDSTAR ECO 8F ULTRASOUND CATHETERBIOSENSE WEBSTER INC2020-03-18
OPTICROSS 6 HDBOSTON SCIENTIFIC CORPORATION2020-03-18
OPTICROSS HDBOSTON SCIENTIFIC CORPORATION2020-03-17
SOUNDSTAR ECO 8F ULTRASOUND CATHETERBIOSENSE WEBSTER INC.2020-03-17
VIEWFLEX? XTRA ICE CATHETERST. JUDE MEDICAL, INC2020-03-17
VIEWFLEX? XTRA ICE CATHETERST. JUDE MEDICAL, INC.2020-03-17
VIEWFLEX? XTRA ICE CATHETERST. JUDE MEDICAL, COSTA RICA LTDA2020-03-17
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-12
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-12
ACUSON ACUNAV VOLUME ICE CATHETERSIEMENS MEDICAL SOLUTIONS USA, INC.2020-03-12
EAGLE EYE PLATINUMPHILIPS2020-03-10
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-09
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-03-09
OPTICROSS HDBOSTON SCIENTIFIC CORPORATION2020-03-05
ARROW VASCULAR POSITIONING SYSTEMARROW INTERNATIONAL INC.2020-03-02
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-02-28
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-02-27
EAGLE EYE PLATINUM ST CATHETERPHILIPS VOLCANO2020-02-27
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETERBIOSENSE WEBSTER INC2020-02-26
ARROW ARROW(R) VPS(R) ACCESS KITARROW INTERNATIONAL INC.2020-02-26
ARROW ARROW(R) VPS(R) ACCESS KITARROW INTERNATIONAL INC.2020-02-26
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-02-25
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-02-25
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-02-24
VIEWFLEX? XTRA ICE CATHETERST. JUDE MEDICAL, INC.2020-02-24
SOUNDSTAR? ECO DIAGNOSTIC ULTRASOUND CATHETERBIOSENSE WEBSTER INC2020-02-21
OPTICROSS HDBOSTON SCIENTIFIC CORPORATION2020-02-20
OPTICROSS 6BOSTON SCIENTIFIC CORPORATION2020-02-20
SOUNDSTAR ECO 8F ULTRASOUND CATHETERBIOSENSE WEBSTER INC2020-02-13
OPTICROSS HDBOSTON SCIENTIFIC CORPORATION2020-02-13
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-02-11
OPTICROSS 6 HDBOSTON SCIENTIFIC CORPORATION2020-02-11
OPTICROSS HDBOSTON SCIENTIFIC CORPORATION2020-02-11
SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETERBIOSENSE WEBSTER INC2020-02-10
VIEWFLEX? XTRA ICE CATHETERST. JUDE MEDICAL, INC.2020-02-10
SOUNDSTAR ECO 8F ULTRASOUND CATHETERBIOSENSE WEBSTER INC2020-02-08
EAGLE EYE PLATINUM CATHETERPHILIPS VOLCANO2020-02-06
OPTICROSSBOSTON SCIENTIFIC CORPORATION2020-02-05
OPTICROSS HDBOSTON SCIENTIFIC CORPORATION2020-02-05
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