510(k) K200030 ยท HCG Device, Neurovascular Embolization
Optima Coil System
| Applicant | Balt USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 1, 2020 |
| Received | Jan 7, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2025 | BALT USA, LLC Optima Coil System REFs/UDI-DI codes:
OPTI0156BLK 00810068568875
OPTI0158BLK 00810068568882
OPTI0103BLK 00810068568851
OPTI0258BLK 00810068568929
OPTI0212BLK 00810068568912
OPTI0206BLK 00810068568905
Open, Classified |
HCG | None listed |
| 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 |
| Oct 20, 2022 | BALT USA, LLC Optima Coil System
Model Number OPTI0208CSS10,
Model Number OPTI0308CSS10. Used in endovascular procedures. Open, Classified |
HCG | None listed |
| Jul 26, 2022 | BALT USA, LLC Optima Coil System Model OPTI0520CSF10. For endovascular embolization. Open, Classified |
HCG | None listed |
| Jan 4, 2022 | BALT USA, LLC The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a Open, Classified |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.