Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200) → OBJ — Catheter, Ultrasound, Intravascular # OBJ · Catheter, Ultrasound, Intravascular _Cardiovascular · 21 CFR 870.1200 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ ## Overview - **Product Code:** OBJ - **Device Name:** Catheter, Ultrasound, Intravascular - **Regulation:** [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 78) Showing 20 most recent of 78 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252945](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K252945.md) | Novasight Hybrid System | Conavi Medical, Inc. | Apr 17, 2026 | SESE | | [K260816](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K260816.md) | 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 | Apr 8, 2026 | SESE | | [K253399](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K253399.md) | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device | Oct 28, 2025 | SESE | | [K250955](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K250955.md) | XC11 ICE System, USA | Yorlabs, Inc. | Oct 22, 2025 | SESE | | [K250913](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K250913.md) | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | Jul 19, 2025 | SESE | | [K251211](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K251211.md) | 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 | May 23, 2025 | SESE | | [K251231](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K251231.md) | ViewFlex™ X ICE Catheter, Sensor Enabled™ | ABBOTT MEDICAL | May 20, 2025 | SESE | | [K251103](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K251103.md) | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation | May 9, 2025 | SESE | | [K242893](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K242893.md) | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | Mar 24, 2025 | SESE | | [K241540](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K241540.md) | NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | Jun 28, 2024 | SESE | | [K240050](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K240050.md) | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | Jun 12, 2024 | SESE | | [K233948](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K233948.md) | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | Apr 23, 2024 | SESE | | [K233270](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K233270.md) | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | Oct 28, 2023 | SESE | | [K230453](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K230453.md) | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | Boston Scientific Corporation | May 18, 2023 | SESE | | [K223766](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K223766.md) | NUVISION™ NAV Ultrasound Catheter | Biosense Webster, Inc. | Feb 16, 2023 | SESE | | [K223077](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K223077.md) | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | Dec 7, 2022 | SESE | | [K222568](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K222568.md) | OptiCross™ 18 Peripheral Imaging Catheter | Boston Scientific Corporation | Sep 23, 2022 | SESE | | [K213593](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K213593.md) | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Boston Scientific Corporation | Jan 14, 2022 | SESE | | [K212959](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K212959.md) | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. | Oct 15, 2021 | SESE | | [K201775](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K201775.md) | NuVision ICE Catheter | Nuvera Medical, Inc. | Mar 5, 2021 | SESE | ## Top Applicants - Volcano Corporation — 14 clearances - Siemens Medical Solutions USA, Inc. — 11 clearances - Biosense Webster, Inc. — 8 clearances - Boston Scientific Corporation — 8 clearances - Vasonova, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com