Device Classification Name |
device, vascular, for promoting embolization
|
510(k) Number |
K122543 |
Device Name |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
Applicant |
MICROVENTION, INC. |
1311 VALENCIA AVE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
LARAINE PANGELINA |
Correspondent |
MICROVENTION, INC. |
1311 VALENCIA AVE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
LARAINE PANGELINA |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 08/21/2012 |
Decision Date | 11/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|