K102365 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM- COSMOS. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 18, 2010, 90 days after receiving the submission on August 20, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K102365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2010 |
| Decision Date | November 18, 2010 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | KRD — Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |