Catheter, Ultrasound, Intravascular
FDA product code OBJ · Class II (moderate risk) · 21 CFR 870.1200 · Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
80510(k) clearances
0PMA approvals
23recalls
Manufacturers
- Volcano Corporation 14
- Siemens Medical Solutions USA, Inc. 12
- Boston Scientific Corporation 12
- Biosense Webster, Inc. 9
- Vasonova, Inc. 5
- Philips Image Guided Therapy Corporation 3
- Acist Medical Systems, Inc. 3
- Luma Vision Limited 2
- Abbott Medical 2
- Silicon Vally Medical Instruments, Inc. 2
- Conavi Medical, Inc. 2
- Arrow International (Subsidiary of Teleflex Inc.) 1
- Volcano Corporation (Dba Philips Image Guided Therapy Device 1
- Nuvera Medical, Inc. 1
- Northeast Scientific Inc. 1
- Arrow International, Inc (Subsidiary of Teleflex I 1
- Irvine Biomedical Inc, a St. Jude Medical Co. 1
- Cd Leycom BV 1
- Boston Scientific Scimed, Inc. 1
- Volcano Therapeutics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261696 | ACUNAV Luxera 4D ICE CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 09/10/2026SE |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002)OBJ · Special | Luma Vision Limited | 07/24/2026SE |
| K252945 | Novasight Hybrid SystemOBJ · Traditional | Conavi Medical, Inc. | 04/17/2026SE |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…OBJ · Special | Boston Scientific | 04/08/2026SE |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterOBJ · Special | Volcano Corporation (Dba Philips Image Guided… | 10/28/2025SE |
| K250955 | XC11 ICE System, USAOBJ · Traditional | Yorlabs, Inc. | 10/22/2025SE |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemOBJ · Traditional | Jiangsu Tingsn Technology Co., Ltd. | 07/19/2025SE |
| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid…OBJ · Special | Abbott Medical | 05/23/2025SE |
| K251231 | ViewFlex X ICE Catheter, Sensor EnabledOBJ · Special | Abbott Medical | 05/20/2025SE |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac…OBJ · Special | Philips Image Guided Therapy Corporation | 05/09/2025SE |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemOBJ · Traditional | Luma Vision Limited | 03/24/2025SE |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound CatheterOBJ · Special | Biosense Webster, Inc. | 06/28/2024SE |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound CatheterOBJ · Special | Biosense Webster, Inc. | 06/12/2024SE |
| K233948 | Provisio SLT IVUS SystemOBJ · Traditional | Provisio Medical, Inc. | 04/23/2024SE |
| K233270 | AcuNav Crystal Ultrasound CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 10/28/2023SE |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterOBJ · Special | Boston Scientific Corporation | 05/18/2023SE |
| K223766 | NUVISION NAV Ultrasound CatheterOBJ · Traditional | Biosense Webster, Inc. | 02/16/2023SE |
| K223077 | ViewFlex Xtra ICE CatheterOBJ · Special | Irvine Biomedical, A St. Jude Medical Company | 12/07/2022SE |
| K222568 | OptiCross 18 Peripheral Imaging CatheterOBJ · Special | Boston Scientific Corporation | 09/23/2022SE |
| K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDOBJ · Special | Boston Scientific Corporation | 01/14/2022SE |
| K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 10/15/2021SE |
| K201775 | NuVision ICE CatheterOBJ · Traditional | Nuvera Medical, Inc. | 03/05/2021SE |
| K203726 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 01/19/2021SE |
| K200812 | VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE CatheterOBJ · Traditional | Philips Image Guided Therapy Corporation | 09/02/2020SE |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS CatheterOBJ · Traditional | Northeast Scientific, Inc. | 06/22/2020SE |
| K200410 | Reconnaissance PV .018 OTW Digital IVUS CatheterOBJ · Traditional | Philips Image Guided Therapy Corporation | 05/22/2020SE |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ · Special | Acist Medical Systems, Inc. | 03/20/2020SE |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Traditional | Acist Medical Systems, Inc. | 06/27/2019SE |
| K172258 | Novasight Hybrid SystemOBJ · Traditional | Conavi Medical, Inc. | 04/27/2018SE |
| K173820 | OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…OBJ · Special | Boston Scientific Corporation | 01/17/2018SE |
| K173618 | ACUSON AcuNav Volume Intracardiac Echocardiography CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 12/19/2017SE |
| K173284 | OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz…OBJ · Special | Boston Scientific Corporation | 11/16/2017SE |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Special | Acist Medical Systems, Inc. | 10/23/2017SE |
| K170992 | AcuNav V 10F Ultrasound CatheterOBJ · Traditional | Siemens Medical Solutions USA, Inc. | 06/15/2017SE |
| K170263 | AcuNav Diagnostic Ultrasound Catheter 8F,10FOBJ · Special | Siemens Medical Solutions USA, Inc. | 06/15/2017SE |
| K163478 | AcuNav Volume ICE CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 02/09/2017SE |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipOBJ · Traditional | Volcano Corporation | 10/26/2016SE |
| K160514 | OptiCross 18, 30 MHz Peripheral Imaging CatheterOBJ · Traditional | Boston Scientific Corporation | 06/22/2016SE |
| K161125 | OptiCross X, 40 MHz Coronary Imaging CatheterOBJ · Special | Boston Scientific Corporation | 05/19/2016SE |
| K153617 | OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…OBJ · Special | Boston Scientific Corporation | 02/25/2016SE |
| K153094 | Visions PV .035 Digital IVUS CatheterOBJ · Special | Volcano Corporation | 12/31/2015SE |
| K152829 | Visions PV.014P RX Digital IVUS CatheterOBJ · Special | Volcano Corporation | 11/19/2015SE |
| K150442 | Volcano Visions PV .018 Digital IVUS CatheterOBJ · Traditional | Volcano Corporation | 09/04/2015SE |
| K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…OBJ · Traditional | Volcano Corporation | 08/26/2015SE |
| K141618 | Arrow VPS Stylet Plus and Cg+ Arrow Picc Powered by Arrow VPS Stylet PlusOBJ · Special | Arrow International, Inc (Subsidiary of Teleflex I | 07/08/2014SE |
| K133853 | Viewflex Xtra Ice CatheterOBJ · Traditional | Irvine Biomedical, Inc., A St. Jude Medical… | 05/19/2014SE |
| K140318 | Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound CatheterOBJ · Special | Biosense Webster | 03/12/2014SE |
| K132133 | Cg+ Arrow Jacc Powered by Arrow VPS StyletOBJ · Special | Arrow International (Subsidiary of Teleflex Inc.) | 09/26/2013SE |
| K123621 | Opticross 40 MHZ Coronary Imaging CatheterOBJ · Traditional | Boston Scientific Corp | 04/15/2013SE |
| K123813 | Vascular Positioning System (VPS) G4 ConsoleOBJ · Special | Vasonova, Inc. | 01/18/2013SE |
| K122878 | Hd-Ivus Ultrasound Imaging SystemOBJ · Special | Silicon Vally Medical Instruments, Inc. | 01/11/2013SE |
| K121273 | Visions PV .035 Ditital Ivus CatheterOBJ · Abbreviated | Volcano Corporation | 09/10/2012SE |
| K113008 | Kodama Intravascular Ulrasound CatheterOBJ · Traditional | Silicon Vally Medical Instruments, Inc. | 06/14/2012SE |
| K120697 | Eagle Eye Platinum ST CatheterOBJ · Special | Volcano Corporation | 04/05/2012SE |
| K112050 | Soundstar Eco Diagnostic Ultrasound CatheterOBJ · Special | Biosense Webster, Inc. | 11/18/2011SE |
| K111043 | Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterOBJ · Traditional | Boston Scientific Corp | 08/04/2011SE |
| K103260 | Vascular Positioning System (VPS System) ConsoleOBJ · Traditional | Vasonova, Inc. | 02/18/2011SE |
| K103255 | Vascular Positioning System TM (VPS TM System) StyletOBJ · Traditional | Vasonova, Inc. | 02/18/2011SE |
| K101138 | Soundstar 3D Ultrasound Catheter Model M-5723-12OBJ · Special | Biosense Webster, Inc. | 06/22/2010SE |
| K092596 | Eagle Eye Platinum Digital Ivus CatheterOBJ · Abbreviated | Volcano Corporation | 12/10/2009SE |
| K091352 | Soundstar 3D Diagnostic Catheter, Model M-5723-05OBJ · Special | Biosense Webster, Inc. | 12/04/2009SE |
| K092064 | Soundstar 3D Ultrasound Catheter, Model M-5723-12OBJ · Special | Biosense Webster, Inc. | 08/07/2009SE |
| K081626 | Flowpicc ConsoleOBJ · Traditional | Vasonova, Inc. | 10/15/2008SE |
| K081808 | Acunav V Ultrasound CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 09/26/2008SE |
| K081625 | Flowpicc StyletOBJ · Traditional | Vasonova, Inc. | 09/26/2008SE |
| K080891 | Revolution 45MHZ Ivus Imaging CatheterOBJ · Special | Volcano Corporation | 05/12/2008SE |
| K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter…OBJ · Special | Volcano Corporation | 01/14/2008SE |
| K071554 | Volcano S5/S5I Intravascular Imaging and Pressure SystemOBJ · Special | Volcano Corporation | 01/04/2008SE |
| K071660 | Visions PV 8.2 Intravascular Ultrasound Imaging Catheter, Model 88900OBJ · Special | Volcano Corporation | 08/31/2007SE |
| K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10FOBJ · Traditional | Siemens Medical Solutions USA, Inc. | 06/29/2007SE |
| K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05OBJ · Traditional | Biosense Webster, Inc. | 05/15/2007SE |
| K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano Vh-Ivus System, Model…OBJ · Special | Volcano Corporation | 08/18/2005SE |
| K051679 | Ilab Ultrasound Imaging SystemOBJ · Special | Boston Scientific Corp | 07/14/2005SE |
| K050995 | Revolution 45 MHZ Rotational Ivus Imaging CatheterOBJ · Special | Volcano Corporation | 06/20/2005SE |
| K042593 | Acuson Acunav 8F Ultrasound CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 10/15/2004SE |
| K041727 | Modification to Atlantis PV Imaging Catheter, Model 36456OBJ · Special | Boston Scientific Scimed, Inc. | 07/23/2004SE |
| K041134 | Combomap Pressure and Flow SystemOBJ · Special | Volcano Therapeutics, Inc. | 06/02/2004SE |
| K033650 | Acunav 90/10 Diagnostic Ultrasound CatheterOBJ · Traditional | Siemens Medical Solutions USA, Inc. | 02/24/2004SE |
| K031346 | Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900OBJ · Special | Jomed, Inc. | 06/23/2003SE |
| K030524 | CD Leycom 7 FR Pressure/Volume Catheter (10 MM Electrode Spacing) Pressure/Volume…OBJ · Special | Cd Leycom BV | 03/03/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2379-2026 Class I | Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2221-2025 Class II | Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF:…Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter… | Volcano Corp | 06/13/2025Open, Classified |
| Z-1585-2025 Class I | Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter…Due to manufacturing issues there is a potential for the catheter sheath to detach. | Conavi Medical Inc. | 03/12/2025Open, Classified |
| Z-1396-2024 Class II | OptiCross Coronary Imaging Catheter, REF H749518080120Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage… | Boston Scientific Corporation | 03/05/2024Open, Classified |
| Z-1302-2022 Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only…Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Volcano Corp | 05/13/2022Open, Classified |
| Z-1301-2022 Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only…Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Volcano Corp | 05/13/2022Open, Classified |
| Z-1161-2021 Class I | ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound…Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the… | Acist Medical Systems | 01/22/2021Terminated |
| Z-0181-2021 Class II | Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date…Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length… | Boston Scientific Corporation | 08/24/2020Terminated |
| Z-0090-2021 Class II | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5FDue to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. | Siemens Medical Solutions USA, Inc. | 05/22/2020Terminated |
| Z-0727-2019 Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272…Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the… | Volcano Corporation | 10/17/2018Terminated |
| Z-0726-2019 Class II | Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173…Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the… | Volcano Corporation | 10/17/2018Terminated |
| Z-2015-2018 Class II | ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNMProduct sterility may be compromised due to unsealed packaging. | Arrow International Inc | 04/11/2018Terminated |
| Z-0189-2018 Class II | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF…On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the… | Volcano Corporation | 11/03/2017Terminated |
| Z-0179-2018 Class II | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous…There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the… | Arrow International Inc | 06/01/2017Terminated |
| Z-2170-2017 Class II | Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous…Arrow International is notifying each customer who received the affected that product that the kits do not… | Arrow International Inc | 04/28/2017Terminated |
| Z-1776-2017 Class II | Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number:…High complaint rates of kinking near the junction of the proximal shaft to telescope section of the… | Volcano Corporation | 03/29/2017Terminated |
| Z-1775-2017 Class II | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number:…High complaint rates of kinking near the junction of the proximal shaft to telescope section of the… | Volcano Corporation | 03/29/2017Terminated |
| Z-1813-2016 Class II | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4…Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In… | Volcano Corporation | 04/25/2016Terminated |
| Z-0003-2016 Class II | SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and…Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting… | Biosense Webster, Inc. | 09/10/2015Terminated |
| Z-2489-2015 Class II | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component…saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No… | Arrow International Inc | 07/30/2015Terminated |
| Z-1844-2015 Class II | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is…During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in… | Volcano Corporation | 06/04/2015Terminated |
| Z-1408-2015 Class II | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C…A limited number of VPS G4 Consoles are being recalled due to noncompliance with International… | VasoNova, Inc. | 03/30/2015Terminated |
| Z-1030-2015 Class III | Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial…Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size… | Arrow International Inc | 01/09/2015Terminated |