510(k) K253511 · KRD Device, Vascular, For Promoting Embolization
Concerto Versa Detachable Coil
| Applicant | Medtronic, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 14, 2026 |
| Received | Nov 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253511
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.