OBJ · Catheter, Ultrasound, Intravascular
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | OBJ |
|---|---|
| Device Name | Catheter, Ultrasound, Intravascular |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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 | Novasight Hybrid System | Conavi Medical, Inc. | Apr 17, 2026 | SESE |
| 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 | Apr 8, 2026 | SESE |
| K253399 | 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 | XC11 ICE System, USA | Yorlabs, Inc. | Oct 22, 2025 | SESE |
| K250913 | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | Jul 19, 2025 | SESE |
| 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 | May 23, 2025 | SESE |
| K251231 | ViewFlex X ICE Catheter, Sensor Enabled | ABBOTT MEDICAL | May 20, 2025 | SESE |
| K251103 | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation | May 9, 2025 | SESE |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | Mar 24, 2025 | SESE |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. | Jun 28, 2024 | SESE |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | Jun 12, 2024 | SESE |
| K233948 | Provisio SLT IVUS System | Provisio Medical, Inc. | Apr 23, 2024 | SESE |
| K233270 | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | Oct 28, 2023 | SESE |
| K230453 | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter | Boston Scientific Corporation | May 18, 2023 | SESE |
| K223766 | NUVISION NAV Ultrasound Catheter | Biosense Webster, Inc. | Feb 16, 2023 | SESE |
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | Dec 7, 2022 | SESE |
| K222568 | OptiCross 18 Peripheral Imaging Catheter | Boston Scientific Corporation | Sep 23, 2022 | SESE |
| K213593 | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | Boston Scientific Corporation | Jan 14, 2022 | SESE |
| K212959 | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | Siemens Medical Solutions USA, Inc. | Oct 15, 2021 | SESE |
| K201775 | 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
