Device Classification Name |
Device, Vascular, For Promoting Embolization
|
510(k) Number |
K192083 |
Device Name |
Okami Medical LOBO Vascular Occlusion System |
Applicant |
Okami Medical |
8 Argonaut, Suite 100 |
Aliso Viejo,
CA
92656
|
|
Applicant Contact |
Rebecca K Pine |
Correspondent |
Okami Medical |
8 Argonaut, Suite 100 |
Aliso Viejo,
CA
92656
|
|
Correspondent Contact |
Rebecca K Pine |
Regulation Number | 870.3300
|
Classification Product Code |
|
Date Received | 08/02/2019 |
Decision Date | 10/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|