K200030 is an FDA 510(k) clearance for the Optima Coil System. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on February 1, 2020, 25 days after receiving the submission on January 7, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K200030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2020 |
| Decision Date | February 01, 2020 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCG - Device, Neurovascular Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5950 |