K100454 is an FDA 510(k) clearance for the HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V. 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 April 22, 2010, 64 days after receiving the submission on February 17, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K100454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2010 |
| Decision Date | April 22, 2010 |
| Days to Decision | 64 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 |