Panels › Cardiovascular › Product code OBJ · Class 2
Catheter, Ultrasound, Intravascular
Regulation 870.1200
4510(k)s in 12 months (80 all time)
1recalls in 12 months (23 all time)
23recalls that name a 510(k)
Top companies in OBJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Volcano Corporation | 14 | 10 |
| Boston Scientific | 12 | 2 |
| Siemens Medical Solutions USA, Inc. | 12 | 1 |
| Biosense Webster | 9 | 1 |
| ARROW INTERNATIONAL, LLC | 0 | 6 |
| Vasonova, Inc. | 5 | 1 |
| Acist Medical Systems, Inc. | 3 | 1 |
| Conavi Medical, Inc. | 2 | 1 |
| Philips Image Guided Therapy Corporation | 3 | 0 |
| ABBOTT MEDICAL | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2026 | K261696 | ACUNAV Luxera 4D ICE Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| Jul 24, 2026 | K261849 | VERAFEYE Imaging Catheter (VF-VIC-002) Luma Vision Limited, IE | OBJ |
| Apr 17, 2026 | K252945 | Novasight Hybrid System Conavi Medical, Inc., CA | OBJ |
| Apr 8, 2026 | K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coro Boston Scientific | OBJ |
| Oct 28, 2025 | K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter Volcano Corporation (Dba Philips Image Guided Therapy Device | OBJ |
| Oct 22, 2025 | K250955 | XC11 ICE System, USA Yorlabs, Inc. | OBJ |
| Jul 19, 2025 | K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System Jiangsu Tingsn Technology Co., Ltd., CN | OBJ |
| May 23, 2025 | K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; ABBOTT MEDICAL | OBJ |
| May 20, 2025 | K251231 | ViewFlex X ICE Catheter, Sensor Enabled ABBOTT MEDICAL | OBJ |
| May 9, 2025 | K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3 Philips Image Guided Therapy Corporation | OBJ |
| Mar 24, 2025 | K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System Luma Vision Limited, IE | OBJ |
| Jun 28, 2024 | K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter Biosense Webster, Inc. | OBJ |
| Jun 12, 2024 | K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter Biosense Webster, Inc. | OBJ |
| Apr 23, 2024 | K233948 | Provisio SLT IVUS System Provisio Medical, Inc. | OBJ |
| Oct 28, 2023 | K233270 | AcuNav Crystal Ultrasound Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| May 18, 2023 | K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter Boston Scientific Corporation | OBJ |
| Feb 16, 2023 | K223766 | NUVISION NAV Ultrasound Catheter Biosense Webster, Inc. | OBJ |
| Dec 7, 2022 | K223077 | ViewFlex Xtra ICE Catheter Irvine Biomedical, A St. Jude Medical Company | OBJ |
| Sep 23, 2022 | K222568 | OptiCross 18 Peripheral Imaging Catheter Boston Scientific Corporation | OBJ |
| Jan 14, 2022 | K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD Boston Scientific Corporation | OBJ |
| Oct 15, 2021 | K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| Mar 5, 2021 | K201775 | NuVision ICE Catheter Nuvera Medical, Inc. | OBJ |
| Jan 19, 2021 | K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| Sep 2, 2020 | K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter Philips Image Guided Therapy Corporation | OBJ |
| Jun 22, 2020 | K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter Northeast Scientific, Inc. | OBJ |
| May 22, 2020 | K200410 | Reconnaissance PV .018 OTW Digital IVUS Catheter Philips Image Guided Therapy Corporation | OBJ |
| Mar 20, 2020 | K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter Acist Medical Systems, Inc. | OBJ |
| Jun 27, 2019 | K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System Acist Medical Systems, Inc. | OBJ |
| Apr 27, 2018 | K172258 | Novasight Hybrid System Conavi Medical, Inc., CA | OBJ |
| Jan 17, 2018 | K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation | OBJ |
| Dec 19, 2017 | K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| Nov 16, 2017 | K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) Boston Scientific Corporation | OBJ |
| Oct 23, 2017 | K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System Acist Medical Systems, Inc. | OBJ |
| Jun 15, 2017 | K170992 | AcuNav V 10F Ultrasound Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| Jun 15, 2017 | K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10F Siemens Medical Solutions USA, Inc. | OBJ |
| Feb 9, 2017 | K163478 | AcuNav Volume ICE Catheter Siemens Medical Solutions USA, Inc. | OBJ |
| Oct 26, 2016 | K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip Volcano Corporation | OBJ |
| Jun 22, 2016 | K160514 | OptiCross 18, 30 MHz Peripheral Imaging Catheter Boston Scientific Corporation | OBJ |
| May 19, 2016 | K161125 | OptiCross X, 40 MHz Coronary Imaging Catheter Boston Scientific Corporation | OBJ |
| Feb 25, 2016 | K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distr Boston Scientific Corporation | OBJ |
| Dec 31, 2015 | K153094 | Visions PV .035 Digital IVUS Catheter Volcano Corporation | OBJ |
| Nov 19, 2015 | K152829 | Visions PV.014P RX Digital IVUS Catheter Volcano Corporation | OBJ |
| Sep 4, 2015 | K150442 | Volcano Visions PV .018 Digital IVUS Catheter Volcano Corporation | OBJ |
| Aug 26, 2015 | K143701 | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM Volcano Corporation | OBJ |
| Jul 8, 2014 | K141618 | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS Arrow International, Inc (Subsidiary of Teleflex I | OBJ |
| May 19, 2014 | K133853 | VIEWFLEX XTRA ICE CATHETER Irvine Biomedical, Inc., A St. Jude Medical Company | OBJ |
| Mar 12, 2014 | K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER Biosense Webster | OBJ |
| Sep 26, 2013 | K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.) | OBJ |
| Apr 15, 2013 | K123621 | OPTICROSS 40 MHZ CORONARY IMAGING CATHETER Boston Scientific Corp | OBJ |
| Jan 18, 2013 | K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE Vasonova, Inc. | OBJ |
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