K242893
- 510(k) number
- K242893
- Device name
- VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
- Applicant
- Luma Vision Limited IE
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2025-03-24
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242893.pdf
Official FDA record: K242893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.