K161367 is an FDA 510(k) clearance for the 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 August 31, 2016, 106 days after receiving the submission on May 17, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K161367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2016 |
| Decision Date | August 31, 2016 |
| Days to Decision | 106 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 |