510(k) K261849 ยท OBJ Catheter, Ultrasound, Intravascular
VERAFEYE Imaging Catheter (VF-VIC-002)
| Applicant | Luma Vision Limited, Dublin, IE |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Jun 3, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261849
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.