The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Microplex Coil System- Cosmos.
| Device ID | K102365 |
| 510k Number | K102365 |
| Device Name: | MICROPLEX COIL SYSTEM- COSMOS |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2010-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170014222 | K102365 | 000 |
| 00810170014208 | K102365 | 000 |
| 00810170014161 | K102365 | 000 |
| 00810170014147 | K102365 | 000 |
| 00810170014130 | K102365 | 000 |
| 00810170014123 | K102365 | 000 |