510(k) K242893
K242893 is an FDA 510(k) premarket notification submitted by Luma Vision Limited for the device "VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System". The FDA issued a decision of Substantially Equivalent on March 24, 2025. 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 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2025
- Date Received
- September 23, 2024
- Clearance Type
- Traditional
- 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.