510(k) K251383 ยท KRD Device, Vascular, For Promoting Embolization
Prestige Coil System (Prestige Packing Line Extension)
| Applicant | Balt USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | May 2, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251383
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.