510(k) K254221 ยท HCG Device, Neurovascular Embolization
Optima Coil System (OptiOne Coil System)
| Applicant | Balt USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 27, 2026 |
| Received | Dec 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254221
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.