The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Hydrosoft And Hydrosoft Plus Embolization Coil Systems.
| Device ID | K080666 |
| 510k Number | K080666 |
| Device Name: | HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
| Contact | Kevin E Daly |
| Correspondent | Kevin E Daly MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-07-11 |
| Summary: | summary |