510(k) K242893 ยท OBJ Catheter, Ultrasound, Intravascular
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
| Applicant | Luma Vision Limited, Dublin, IE |
| Decision | Substantially Equivalent, Mar 24, 2025 |
| Received | Sep 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242893
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.