The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10.
| Device ID | K103758 |
| 510k Number | K103758 |
| Device Name: | MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina 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 | 2010-12-23 |
| Decision Date | 2011-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816777026538 | K103758 | 000 |
| 00810170015601 | K103758 | 000 |
| 00811425020227 | K103758 | 000 |
| 00811425020234 | K103758 | 000 |
| 00811425027028 | K103758 | 000 |
| 00811425027035 | K103758 | 000 |
| 00812636029740 | K103758 | 000 |
| 00812636029757 | K103758 | 000 |
| 00816777023476 | K103758 | 000 |
| 00816777023483 | K103758 | 000 |
| 00816777026484 | K103758 | 000 |
| 00810170015595 | K103758 | 000 |