K203625 is an FDA 510(k) clearance for the Numen Coil Embolization System. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by MicroPort NeuroTech (Shanghai) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 1, 2021, 264 days after receiving the submission on December 11, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K203625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2020 |
| Decision Date | September 01, 2021 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| 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 |