Device Classification Name |
device, neurovascular embolization
|
510(k) Number |
K172390 |
Device Name |
Optima Coil System |
Applicant |
Blockade Medical, LLC (d.b.a. Balt USA) |
18 Technology Dr. Ste 169 |
Irvine,
CA
92618
|
|
Applicant Contact |
Rebecca K. Pine |
Correspondent |
Blockade Medical, LLC (d.b.a. Balt USA) |
18 Technology Dr. Ste 169 |
Irvine,
CA
92618
|
|
Correspondent Contact |
Rebecca K. Pine |
Regulation Number | 882.5950
|
Classification Product Code |
|
Date Received | 08/08/2017 |
Decision Date | 02/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|