K153594 is an FDA 510(k) clearance for the MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES). This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on January 22, 2016, 37 days after receiving the submission on December 16, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K153594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2015 |
| Decision Date | January 22, 2016 |
| Days to Decision | 37 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 |