510(k) K261849
K261849 is an FDA 510(k) premarket notification submitted by Luma Vision Limited for the device "VERAFEYE Imaging Catheter (VF-VIC-002)". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Luma Vision Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2026
- Date Received
- June 3, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.