OBJ
- Product code
- OBJ
- Device name
- Catheter, Ultrasound, Intravascular
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 14
- Summaries archived here
- 14 (direct download)
- 510(k) clearances (all years, FDA)
- 79 (all years; only the last 3 years are listed here)
FDA classification definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261849 | 2026-07-24 | Luma Vision Limited | VERAFEYE Imaging Catheter (VF-VIC-002) | |
| K252945 | 2026-04-17 | Conavi Medical, Inc. | Novasight Hybrid System | |
| K260816 | 2026-04-08 | Boston Scientific | OptiCross Coronary Imaging Catheter (H749518110); Op… | |
| K253399 | 2025-10-28 | Volcano Corporation (Dba Philips Image… | Visions® PV .014P RX Digital IVUS Catheter ; Visions… | |
| K250955 | 2025-10-22 | Yorlabs, Inc. | XC11 ICE System, USA | |
| K250913 | 2025-07-19 | Jiangsu Tingsn Technology Co., Ltd. | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound… | |
| K251211 | 2025-05-23 | ABBOTT MEDICAL | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocess… | |
| K251231 | 2025-05-20 | ABBOTT MEDICAL | ViewFlex X ICE Catheter, Sensor Enabled | |
| K251103 | 2025-05-09 | Philips Image Guided Therapy Corporati… | VeriSight Intracardiac Echocardiography Catheter (VS… | |
| K242893 | 2025-03-24 | Luma Vision Limited | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE… | |
| K241540 | 2024-06-28 | Biosense Webster, Inc. | NUVISION Ultrasound Catheter; NUVISION NAV Ultraso… | |
| K240050 | 2024-06-12 | Biosense Webster, Inc. | SOUNDSTAR CRYSTAL Ultrasound Catheter | |
| K233948 | 2024-04-23 | Provisio Medical, Inc. | Provisio SLT IVUS System | |
| K233270 | 2023-10-28 | Siemens Medical Solutions USA, Inc. | AcuNav Crystal Ultrasound Catheter |
Official FDA classification page: OBJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).