Product Code: OBJ
FDA class 2
21 CFR 870.1200
Catheter, Ultrasound, Intravascular
Cardiovascular
The Intravascular Ultrasound Catheter (product code OBJ) is a cardiovascular device designed for intracardiac and intraluminal visualization of cardiovascular anatomy and physiology using ultrasound imaging. It enables real-time assessment of vessel wall morphology, plaque characteristics, and lumen dimensions to guide interventional procedures. This device is FDA Class 2 under regulation 870.1200 in the Cardiovascular specialty, subject to 510(k) clearance and general and special controls. It carries no implant or life-sustaining flags.
510(k)s
73
FEI Numbers
84
Registration Numbers
84
Unique Applicants
30
Years Active
22
Basic Information
- Product Code
- OBJ
- Device Class
- FDA class 2
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 73 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | May 23, 2025 | Substantially Equivalent | Abbott Medical |
| K251231 | ViewFlex X ICE Catheter, Sensor Enabled | May 20, 2025 | Substantially Equivalent | Abbott Medical |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | May 09, 2025 | Substantially Equivalent | Philips Image Guided Therapy Corporation |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Mar 24, 2025 | Substantially Equivalent | Luma Vision Limited |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | Jun 28, 2024 | Substantially Equivalent | Biosense Webster, Inc. |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | Jun 12, 2024 | Substantially Equivalent | Biosense Webster, Inc. |
| K233948 | Provisio SLT IVUS System | Apr 23, 2024 | Substantially Equivalent | Provisio Medical, Inc. |
| K233270 | AcuNav Crystal Ultrasound Catheter | Oct 28, 2023 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | May 18, 2023 | Substantially Equivalent | Boston Scientific Corporation |
| K223766 | NUVISION NAV Ultrasound Catheter | Feb 16, 2023 | Substantially Equivalent | Biosense Webster, Inc. |
| K223077 | ViewFlex Xtra ICE Catheter | Dec 07, 2022 | Substantially Equivalent | Irvine Biomedical, a St. Jude Medical Company |
| K222568 | OptiCross 18 Peripheral Imaging Catheter | Sep 23, 2022 | Substantially Equivalent | Boston Scientific Corporation |
| K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Jan 14, 2022 | Substantially Equivalent | Boston Scientific Corporation |
| K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Oct 15, 2021 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K201775 | NuVision ICE Catheter | Mar 05, 2021 | Substantially Equivalent | NuVera Medical, Inc. |
| K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Jan 19, 2021 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | Sep 02, 2020 | Substantially Equivalent | Philips Image Guided Therapy Corporation |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Jun 22, 2020 | Substantially Equivalent | Northeast Scientific, Inc. |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | May 22, 2020 | Substantially Equivalent | Philips Image Guided Therapy Corporation |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | Mar 20, 2020 | Substantially Equivalent | ACIST Medical Systems, Inc. |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Jun 27, 2019 | Substantially Equivalent | ACIST Medical Systems, Inc. |
| K172258 | Novasight Hybrid System | Apr 27, 2018 | Substantially Equivalent | Conavi Medical Inc. |
| K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) | Jan 17, 2018 | Substantially Equivalent | Boston Scientific Corporation |
| K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | Dec 19, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) | Nov 16, 2017 | Substantially Equivalent | Boston Scientific Corporation |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Oct 23, 2017 | Substantially Equivalent | ACIST Medical Systems, Inc. |
| K170992 | AcuNav V 10F Ultrasound Catheter | Jun 15, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Jun 15, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K163478 | AcuNav Volume ICE Catheter | Feb 09, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | Oct 26, 2016 | Substantially Equivalent | VOLCANO CORPORATION |
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Jun 22, 2016 | Substantially Equivalent | BOSTON SCIENTIFIC CORPORATION |
| K161125 | OptiCross X, 40 MHz Coronary Imaging Catheter | May 19, 2016 | Substantially Equivalent | Boston Scientific Corporation |
| K153617 | 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) | Feb 25, 2016 | Substantially Equivalent | BOSTON SCIENTIFIC CORPORATION |
| K153094 | Visions PV .035 Digital IVUS Catheter | Dec 31, 2015 | Substantially Equivalent | Volcano Corporation |
| K152829 | Visions PV.014P RX Digital IVUS Catheter | Nov 19, 2015 | Substantially Equivalent | Volcano Corporation |
| K150442 | Volcano Visions PV .018 Digital IVUS Catheter | Sep 04, 2015 | Substantially Equivalent | Volcano Corporation |
| K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | Aug 26, 2015 | Substantially Equivalent | VOLCANO CORPORATION |
| K141618 | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS | Jul 08, 2014 | Substantially Equivalent | ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I |
| K133853 | VIEWFLEX XTRA ICE CATHETER | May 19, 2014 | Substantially Equivalent | IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY |
| K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | Mar 12, 2014 | Substantially Equivalent | BIOSENSE WEBSTER |
| K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET | Sep 26, 2013 | Substantially Equivalent | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
| K123621 | OPTICROSS 40 MHZ CORONARY IMAGING CATHETER | Apr 15, 2013 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | Jan 18, 2013 | Substantially Equivalent | VASONOVA INC. |
| K122878 | HD-IVUS ULTRASOUND IMAGING SYSTEM | Jan 11, 2013 | Substantially Equivalent | SILICON VALLY MEDICAL INSTRUMENTS, INC. |
| K121273 | VISIONS PV .035 DITITAL IVUS CATHETER | Sep 10, 2012 | Substantially Equivalent | VOLCANO CORPORATION |
| K113008 | KODAMA INTRAVASCULAR ULRASOUND CATHETER | Jun 14, 2012 | Substantially Equivalent | SILICON VALLY MEDICAL INSTRUMENTS, INC. |
| K120697 | EAGLE EYE PLATINUM ST CATHETER | Apr 05, 2012 | Substantially Equivalent | VOLCANO CORPORATION |
| K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | Nov 18, 2011 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K111043 | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER | Aug 04, 2011 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | Feb 18, 2011 | Substantially Equivalent | VASONOVA INC. |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | Feb 18, 2011 | Substantially Equivalent | VASONOVA INC. |
| K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | Jun 22, 2010 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K092596 | EAGLE EYE PLATINUM DIGITAL IVUS CATHETER | Dec 10, 2009 | Substantially Equivalent | VOLCANO CORPORATION |
| K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 | Dec 04, 2009 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | Aug 07, 2009 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K081626 | FLOWPICC CONSOLE | Oct 15, 2008 | Substantially Equivalent | VASONOVA INC. |
| K081808 | ACUNAV V ULTRASOUND CATHETER | Sep 26, 2008 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA INC. |
| K081625 | FLOWPICC STYLET | Sep 26, 2008 | Substantially Equivalent | VASONOVA INC. |
| K080891 | REVOLUTION 45MHZ IVUS IMAGING CATHETER | May 12, 2008 | Substantially Equivalent | VOLCANO CORPORATION |
| K073473 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 | Jan 14, 2008 | Substantially Equivalent | VOLCANO CORPORATION |
| K071554 | VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM | Jan 04, 2008 | Substantially Equivalent | VOLCANO CORPORATION |
| K071660 | VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 | Aug 31, 2007 | Substantially Equivalent | VOLCANO CORPORATION |
| K071234 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F | Jun 29, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K070242 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 | May 15, 2007 | Substantially Equivalent | BIOSENSE WEBSTER, INC. |
| K051337 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 | Aug 18, 2005 | Substantially Equivalent | VOLCANO CORPORATION |
| K051679 | ILAB ULTRASOUND IMAGING SYSTEM | Jul 14, 2005 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K050995 | REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER | Jun 20, 2005 | Substantially Equivalent | VOLCANO CORPORATION |
| K042593 | ACUSON ACUNAV 8F ULTRASOUND CATHETER | Oct 15, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Jul 23, 2004 | Substantially Equivalent | BOSTON SCIENTIFIC SCIMED, INC. |
| K041134 | COMBOMAP PRESSURE AND FLOW SYSTEM | Jun 02, 2004 | Substantially Equivalent | VOLCANO THERAPEUTICS, INC. |
| K033650 | ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER | Feb 24, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K031346 | JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 | Jun 23, 2003 | Substantially Equivalent | JOMED, INC. |
| K030524 | CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN | Mar 03, 2003 | Substantially Equivalent | CD LEYCOM BV |
FEI Numbers
This FDA classification entry is associated with 84 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 84 registration numbers. Click on an entry to view related FDA registrations.