| Device Classification Name |
device, neurovascular embolization
|
| 510(K) Number |
K020434 |
| Device Name |
MICROPLEX COIL SYSTEM (MCS) |
| Applicant |
| MICROVENTION, INC. |
| 72 argonaut |
|
aliso viejo,
CA
92656 1408
|
|
| Contact |
vincent cutarelli |
| Regulation Number | 882.5950
|
| Classification Product Code |
|
| Date Received | 02/08/2002 |
| Decision Date | 07/29/2002 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Neurology
|
| Review Advisory Committee |
Neurology
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
|
|