FDA Product Code
FDA Product Code OBJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1200
510(k) Clearances — 80 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261696 | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | 2026-09-10 | Special | PDF ↗ |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) | Luma Vision Limited | 2026-07-24 | Special | PDF ↗ |
| K252945 | Novasight Hybrid System | Conavi Medical, Inc. | 2026-04-17 | Traditional | PDF ↗ |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Boston Scientific | 2026-04-08 | Special | PDF ↗ |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device | 2025-10-28 | Special | PDF ↗ |
| K250955 | XC11 ICE System, USA | Yorlabs, Inc. | 2025-10-22 | Traditional | PDF ↗ |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | 2025-07-19 | Traditional | PDF ↗ |
| 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 | ABBOTT MEDICAL | 2025-05-23 | Special | PDF ↗ |
| K251231 | ViewFlex X ICE Catheter, Sensor Enabled | ABBOTT MEDICAL | 2025-05-20 | Special | PDF ↗ |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation | 2025-05-09 | Special | PDF ↗ |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | 2025-03-24 | Traditional | PDF ↗ |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. | 2024-06-28 | Special | PDF ↗ |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | 2024-06-12 | Special | PDF ↗ |
| K233948 | Provisio SLT IVUS System | Provisio Medical, Inc. | 2024-04-23 | Traditional | PDF ↗ |
| K233270 | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2023-10-28 | Special | PDF ↗ |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | Boston Scientific Corporation | 2023-05-18 | Special | PDF ↗ |
| K223766 | NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. | 2023-02-16 | Traditional | PDF ↗ |
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | 2022-12-07 | Special | PDF ↗ |
| K222568 | OptiCross 18 Peripheral Imaging Catheter | Boston Scientific Corporation | 2022-09-23 | Special | PDF ↗ |
| K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Boston Scientific Corporation | 2022-01-14 | Special | PDF ↗ |
| K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. | 2021-10-15 | Special | PDF ↗ |
| K201775 | NuVision ICE Catheter | Nuvera Medical, Inc. | 2021-03-05 | Traditional | PDF ↗ |
| K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. | 2021-01-19 | Special | PDF ↗ |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter | Philips Image Guided Therapy Corporation | 2020-09-02 | Traditional | PDF ↗ |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2020-06-22 | Traditional | PDF ↗ |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter | Philips Image Guided Therapy Corporation | 2020-05-22 | Traditional | PDF ↗ |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | Acist Medical Systems, Inc. | 2020-03-20 | Special | PDF ↗ |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | 2019-06-27 | Traditional | PDF ↗ |
| K172258 | Novasight Hybrid System | Conavi Medical, Inc. | 2018-04-27 | Traditional | PDF ↗ |
| K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) | Boston Scientific Corporation | 2018-01-17 | Special | PDF ↗ |
| K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | Siemens Medical Solutions USA, Inc. | 2017-12-19 | Special | PDF ↗ |
| K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) | Boston Scientific Corporation | 2017-11-16 | Special | PDF ↗ |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | 2017-10-23 | Special | PDF ↗ |
| K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F | Siemens Medical Solutions USA, Inc. | 2017-06-15 | Special | PDF ↗ |
| K170992 | AcuNav V 10F Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2017-06-15 | Traditional | PDF ↗ |
| K163478 | AcuNav Volume ICE Catheter | Siemens Medical Solutions USA, Inc. | 2017-02-09 | Special | PDF ↗ |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | Volcano Corporation | 2016-10-26 | Traditional | PDF ↗ |
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2016-06-22 | Traditional | PDF ↗ |
| K161125 | OptiCross X, 40 MHz Coronary Imaging Catheter | Boston Scientific Corporation | 2016-05-19 | Special | PDF ↗ |
| 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) | Boston Scientific Corporation | 2016-02-25 | Special | PDF ↗ |
| K153094 | Visions PV .035 Digital IVUS Catheter | Volcano Corporation | 2015-12-31 | Special | PDF ↗ |
| K152829 | Visions PV.014P RX Digital IVUS Catheter | Volcano Corporation | 2015-11-19 | Special | PDF ↗ |
| K150442 | Volcano Visions PV .018 Digital IVUS Catheter | Volcano Corporation | 2015-09-04 | Traditional | PDF ↗ |
| K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM | Volcano Corporation | 2015-08-26 | Traditional | PDF ↗ |
| K141618 | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS | Arrow International, Inc (Subsidiary of Teleflex I | 2014-07-08 | Special | PDF ↗ |
| K133853 | VIEWFLEX XTRA ICE CATHETER | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014-05-19 | Traditional | PDF ↗ |
| K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | Biosense Webster | 2014-03-12 | Special | PDF ↗ |
| K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET | Arrow International (Subsidiary of Teleflex Inc.) | 2013-09-26 | Special | PDF ↗ |
| K123621 | OPTICROSS 40 MHZ CORONARY IMAGING CATHETER | Boston Scientific Corp | 2013-04-15 | Traditional | PDF ↗ |
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | Vasonova, Inc. | 2013-01-18 | Special | PDF ↗ |
| K122878 | HD-IVUS ULTRASOUND IMAGING SYSTEM | Silicon Vally Medical Instruments, Inc. | 2013-01-11 | Special | PDF ↗ |
| K121273 | VISIONS PV .035 DITITAL IVUS CATHETER | Volcano Corporation | 2012-09-10 | Abbreviated | PDF ↗ |
| K113008 | KODAMA INTRAVASCULAR ULRASOUND CATHETER | Silicon Vally Medical Instruments, Inc. | 2012-06-14 | Traditional | PDF ↗ |
| K120697 | EAGLE EYE PLATINUM ST CATHETER | Volcano Corporation | 2012-04-05 | Special | PDF ↗ |
| K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | Biosense Webster, Inc. | 2011-11-18 | Special | PDF ↗ |
| K111043 | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER | Boston Scientific Corp | 2011-08-04 | Traditional | PDF ↗ |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | Vasonova, Inc. | 2011-02-18 | Traditional | PDF ↗ |
| K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | Vasonova, Inc. | 2011-02-18 | Traditional | PDF ↗ |
| K101138 | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 | Biosense Webster, Inc. | 2010-06-22 | Special | PDF ↗ |
| K092596 | EAGLE EYE PLATINUM DIGITAL IVUS CATHETER | Volcano Corporation | 2009-12-10 | Abbreviated | PDF ↗ |
| K091352 | SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 | Biosense Webster, Inc. | 2009-12-04 | Special | PDF ↗ |
| K092064 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12 | Biosense Webster, Inc. | 2009-08-07 | Special | PDF ↗ |
| K081626 | FLOWPICC CONSOLE | Vasonova, Inc. | 2008-10-15 | Traditional | PDF ↗ |
| K081625 | FLOWPICC STYLET | Vasonova, Inc. | 2008-09-26 | Traditional | PDF ↗ |
| K081808 | ACUNAV V ULTRASOUND CATHETER | Siemens Medical Solutions USA, Inc. | 2008-09-26 | Special | PDF ↗ |
| K080891 | REVOLUTION 45MHZ IVUS IMAGING CATHETER | Volcano Corporation | 2008-05-12 | Special | PDF ↗ |
| K073473 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700 | Volcano Corporation | 2008-01-14 | Special | PDF ↗ |
| K071554 | VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM | Volcano Corporation | 2008-01-04 | Special | PDF ↗ |
| K071660 | VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 | Volcano Corporation | 2007-08-31 | Special | PDF ↗ |
| K071234 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F | Siemens Medical Solutions USA, Inc. | 2007-06-29 | Traditional | PDF ↗ |
| K070242 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 | Biosense Webster, Inc. | 2007-05-15 | Traditional | PDF ↗ |
| K051337 | EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 | Volcano Corporation | 2005-08-18 | Special | PDF ↗ |
| K051679 | ILAB ULTRASOUND IMAGING SYSTEM | Boston Scientific Corp | 2005-07-14 | Special | PDF ↗ |
| K050995 | REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER | Volcano Corporation | 2005-06-20 | Special | PDF ↗ |
| K042593 | ACUSON ACUNAV 8F ULTRASOUND CATHETER | Siemens Medical Solutions USA, Inc. | 2004-10-15 | Special | PDF ↗ |
| K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Boston Scientific Scimed, Inc. | 2004-07-23 | Special | PDF ↗ |
| K041134 | COMBOMAP PRESSURE AND FLOW SYSTEM | Volcano Therapeutics, Inc. | 2004-06-02 | Special | PDF ↗ |
| K033650 | ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER | Siemens Medical Solutions USA, Inc. | 2004-02-24 | Traditional | PDF ↗ |
| K031346 | JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 | Jomed, Inc. | 2003-06-23 | Special | PDF ↗ |
| K030524 | CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN | Cd Leycom BV | 2003-03-03 | Special | PDF ↗ |
Product code OBJ · Class II · Cardiovascular. Data: openFDA.