510(k) K223386 ยท HCG Device, Neurovascular Embolization
Optima Coil System
| Applicant | Balt USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 6, 2022 |
| Received | Nov 7, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223386
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | BALT USA, LLC Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and o Open, Classified |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.