Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K162999 |
Device Name |
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System |
Applicant |
MICROVENTION, INC |
1311 VALENCIA AVENUE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
Laraine Pangelina |
Correspondent |
MICROVENTION, INC |
1311 VALENCIA AVENUE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
Laraine Pangelina |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 10/28/2016 |
Decision Date | 03/29/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|