Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K151760 |
Device Name |
Barricade Embolization Coil System |
Applicant |
BLOCKADE MEDICAL |
18 Technology Dr Ste 169 |
Irvine,
CA
92618
|
|
Applicant Contact |
REBECCA K. PINE |
Correspondent |
BLOCKADE MEDICAL |
18 Technology Dr Ste 169 |
Irvine,
CA
92618
|
|
Correspondent Contact |
REBECCA K. PINE |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 06/29/2015 |
Decision Date | 07/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|