The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Modification To: Hydrocoil Embolic System (hes).
| Device ID | K041551 |
| 510k Number | K041551 |
| Device Name: | MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent Cutarelli MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-09 |
| Decision Date | 2004-07-07 |
| Summary: | summary |