The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydrocoil(r) Embolic System (hes).
| Device ID | K112181 |
| 510k Number | K112181 |
| Device Name: | HYDROCOIL(R) EMBOLIC SYSTEM (HES) |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Vin Cutarelli |
| Correspondent | Vin Cutarelli MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-28 |
| Decision Date | 2011-12-01 |
| Summary: | summary |