Optima Coil System
FDA 510(k) clearance K200030 · decided 2020-02-01
Clearance details
- K-number
- K200030
- Device name
- Optima Coil System
- Applicant
- Balt USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-01-07
- Decision date
- 2020-02-01
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 0081006856888 recall (Z-1988-2025) | BALT USA, LLC | 2025-06-18 |
| Neurovascular embolization device. The Optima Coil System is a series specialized coils th recall (Z-1041-2024) | BALT USA, LLC | 2024-02-08 |
| Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovas recall (Z-0103-2023) | BALT USA, LLC | 2022-10-20 |