OBJ — Catheter, Ultrasound, Intravascular Class II
FDA product code OBJ covers "Catheter, Ultrasound, Intravascular", a Class II medical device regulated under 21 CFR 870.1200. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OBJ
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252945 | conavi medical | Novasight Hybrid System | April 17, 2026 |
| K260816 | boston scientific | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging C | April 8, 2026 |
| K253399 | volcano corporation (dba philips image guided therapy device | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Cathe | October 28, 2025 |
| K250955 | yorlabs | XC11 ICE System, USA | October 22, 2025 |
| K250913 | jiangsu tingsn technology co | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | July 19, 2025 |
| K251211 | abbott medical | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD | May 23, 2025 |
| K251231 | abbott medical | ViewFlex X ICE Catheter, Sensor Enabled | May 20, 2025 |
| K251103 | philips image guided therapy corporation | VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intrac | May 9, 2025 |
| K242893 | luma vision limited | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | March 24, 2025 |
| K241540 | biosense webster | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter | June 28, 2024 |
| K240050 | biosense webster | SOUNDSTAR CRYSTAL Ultrasound Catheter | June 12, 2024 |
| K233948 | provisio medical | Provisio SLT IVUS System | April 23, 2024 |
| K233270 | siemens medical solutions usa | AcuNav Crystal Ultrasound Catheter | October 28, 2023 |
| K230453 | boston scientific corporation | OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Cath | May 18, 2023 |
| K223766 | biosense webster | NUVISION NAV Ultrasound Catheter | February 16, 2023 |
| K223077 | irvine biomedical, a st. jude medical | ViewFlex Xtra ICE Catheter | December 7, 2022 |
| K222568 | boston scientific corporation | OptiCross 18 Peripheral Imaging Catheter | September 23, 2022 |
| K213593 | boston scientific corporation | OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD | January 14, 2022 |
| K212959 | siemens medical solutions usa | ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter | October 15, 2021 |
| K201775 | nuvera medical | NuVision ICE Catheter | March 5, 2021 |