K261849
- 510(k) number
- K261849
- Device name
- VERAFEYE Imaging Catheter (VF-VIC-002)
- Applicant
- Luma Vision Limited IE
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2026-07-24
- Date received
- 2026-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K261849.pdf
Official FDA record: K261849
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.