FDA 510(k) Applications for Medical Device Product Code "OBJ"
(Catheter, Ultrasound, Intravascular )
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K251231 | Abbott Medical | ViewFlexÖ X ICE Catheter, Sensor EnabledÖ | 05/20/2025 |
| K251211 | Abbott Medical | ViewFlexÖ Xtra ICE Catheter; ViewFlexÖ Eco Reprocessed ICE Catheter; AdvisorÖ HD Grid Mapping Catheter, Sensor EnabledÖ; AdvisorÖ HD Grid X Mapping Catheter, Sensor EnabledÖ; AgilisÖ NxT Steerable Introducer; AgilisÖ NxT Steerable Introducer Dual-ReachÖ | 05/23/2025 |
| K193183 | ACIST Medical Systems, Inc. | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | 03/20/2020 |
| K191175 | ACIST Medical Systems, Inc. | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | 06/27/2019 |
| K173063 | ACIST Medical Systems, Inc. | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | 10/23/2017 |
| K141618 | ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS | 07/08/2014 |
| K132133 | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) | CG+ ARROW JACC POWERED BY ARROW VPS STYLET | 09/26/2013 |
| K140318 | BIOSENSE WEBSTER | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | 03/12/2014 |
| K223766 | Biosense Webster, Inc. | NUVISIONÖ NAV Ultrasound Catheter | 02/16/2023 |
| K241540 | Biosense Webster, Inc. | NUVISIONÖ Ultrasound Catheter; NUVISIONÖ NAV Ultrasound Catheter | 06/28/2024 |
| K091352 | BIOSENSE WEBSTER, INC. | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 | 12/04/2009 |
| K101138 | BIOSENSE WEBSTER, INC. | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | 06/22/2010 |
| K070242 | BIOSENSE WEBSTER, INC. | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 | 05/15/2007 |
| K092064 | BIOSENSE WEBSTER, INC. | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | 08/07/2009 |
| K112050 | BIOSENSE WEBSTER, INC. | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | 11/18/2011 |
| K240050 | Biosense Webster, Inc. | SOUNDSTARÖ CRYSTAL Ultrasound Catheter | 06/12/2024 |
| K111043 | BOSTON SCIENTIFIC CORP. | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER | 08/04/2011 |
| K051679 | BOSTON SCIENTIFIC CORP. | ILAB ULTRASOUND IMAGING SYSTEM | 07/14/2005 |
| K123621 | BOSTON SCIENTIFIC CORP. | OPTICROSS 40 MHZ CORONARY IMAGING CATHETER | 04/15/2013 |
| K160514 | BOSTON SCIENTIFIC CORPORATION | OptiCross 18, 30 MHz Peripheral Imaging Catheter | 06/22/2016 |
| K173820 | Boston Scientific Corporation | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) | 01/17/2018 |
| K153617 | BOSTON SCIENTIFIC CORPORATION | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) | 02/25/2016 |
| K173284 | Boston Scientific Corporation | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) | 11/16/2017 |
| K161125 | Boston Scientific Corporation | OptiCross X, 40 MHz Coronary Imaging Catheter | 05/19/2016 |
| K213593 | Boston Scientific Corporation | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | 01/14/2022 |
| K222568 | Boston Scientific Corporation | OptiCrossÖ 18 Peripheral Imaging Catheter | 09/23/2022 |
| K230453 | Boston Scientific Corporation | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | 05/18/2023 |
| K041727 | BOSTON SCIENTIFIC SCIMED, INC. | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | 07/23/2004 |
| K030524 | CD LEYCOM BV | CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN | 03/03/2003 |
| K172258 | Conavi Medical Inc. | Novasight Hybrid System | 04/27/2018 |
| K223077 | Irvine Biomedical, a St. Jude Medical Company | ViewFlex Xtra ICE Catheter | 12/07/2022 |
| K133853 | IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY | VIEWFLEX XTRA ICE CATHETER | 05/19/2014 |
| K250913 | Jiangsu Tingsn Technology Co., Ltd. | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | 07/19/2025 |
| K031346 | JOMED, INC. | JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 | 06/23/2003 |
| K242893 | Luma Vision Limited | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | 03/24/2025 |
| K200195 | Northeast Scientific, Inc. | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | 06/22/2020 |
| K201775 | NuVera Medical, Inc. | NuVision ICE Catheter | 03/05/2021 |
| K200410 | Philips Image Guided Therapy Corporation | Reconnaissance PV .018 OTW Digital IVUS Catheter | 05/22/2020 |
| K200812 | Philips Image Guided Therapy Corporation | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | 09/02/2020 |
| K251103 | Philips Image Guided Therapy Corporation | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | 05/09/2025 |
| K233948 | Provisio Medical, Inc. | ProvisioÖ SLT IVUSÖ System | 04/23/2024 |
| K081808 | SIEMENS MEDICAL SOLUTIONS USA INC. | ACUNAV V ULTRASOUND CATHETER | 09/26/2008 |
| K170992 | Siemens Medical Solutions USA, Inc | AcuNav V 10F Ultrasound Catheter | 06/15/2017 |
| K033650 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER | 02/24/2004 |
| K233270 | Siemens Medical Solutions USA, Inc. | AcuNav Crystal Ultrasound Catheter | 10/28/2023 |
| K071234 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F | 06/29/2007 |
| K170263 | Siemens Medical Solutions USA, Inc. | AcuNav Diagnostic Ultrasound Catheter 8F,10F | 06/15/2017 |
| K163478 | Siemens Medical Solutions USA, Inc. | AcuNav Volume ICE Catheter | 02/09/2017 |
| K042593 | SIEMENS MEDICAL SOLUTIONS USA, INC. | ACUSON ACUNAV 8F ULTRASOUND CATHETER | 10/15/2004 |
| K173618 | Siemens Medical Solutions USA, Inc. | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | 12/19/2017 |
| K203726 | Siemens Medical Solutions USA, Inc. | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | 01/19/2021 |
| K212959 | Siemens Medical Solutions USA, Inc. | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | 10/15/2021 |
| K122878 | SILICON VALLY MEDICAL INSTRUMENTS, INC. | HD-IVUS ULTRASOUND IMAGING SYSTEM | 01/11/2013 |
| K113008 | SILICON VALLY MEDICAL INSTRUMENTS, INC. | KODAMA INTRAVASCULAR ULRASOUND CATHETER | 06/14/2012 |
| K081626 | VASONOVA INC. | FLOWPICC CONSOLE | 10/15/2008 |
| K081625 | VASONOVA INC. | FLOWPICC STYLET | 09/26/2008 |
| K103260 | VASONOVA INC. | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | 02/18/2011 |
| K123813 | VASONOVA INC. | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | 01/18/2013 |
| K103255 | VASONOVA INC. | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | 02/18/2011 |
| K073473 | VOLCANO CORPORATION | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 | 01/14/2008 |
| K051337 | VOLCANO CORPORATION | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 | 08/18/2005 |
| K143701 | VOLCANO CORPORATION | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | 08/26/2015 |
| K092596 | VOLCANO CORPORATION | EAGLE EYE PLATINUM DIGITAL IVUS CATHETER | 12/10/2009 |
| K120697 | VOLCANO CORPORATION | EAGLE EYE PLATINUM ST CATHETER | 04/05/2012 |
| K160583 | VOLCANO CORPORATION | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | 10/26/2016 |
| K050995 | VOLCANO CORPORATION | REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER | 06/20/2005 |
| K080891 | VOLCANO CORPORATION | REVOLUTION 45MHZ IVUS IMAGING CATHETER | 05/12/2008 |
| K153094 | Volcano Corporation | Visions PV .035 Digital IVUS Catheter | 12/31/2015 |
| K121273 | VOLCANO CORPORATION | VISIONS PV .035 DITITAL IVUS CATHETER | 09/10/2012 |
| K071660 | VOLCANO CORPORATION | VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 | 08/31/2007 |
| K152829 | Volcano Corporation | Visions PV.014P RX Digital IVUS Catheter | 11/19/2015 |
| K071554 | VOLCANO CORPORATION | VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM | 01/04/2008 |
| K150442 | Volcano Corporation | Volcano Visions PV .018 Digital IVUS Catheter | 09/04/2015 |
| K041134 | VOLCANO THERAPEUTICS, INC. | COMBOMAP PRESSURE AND FLOW SYSTEM | 06/02/2004 |
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