Device Classification Name |
Device, Neurovascular Embolization
|
510(k) Number |
K173614 |
Device Name |
Penumbra Coil 400, Ruby Coil System, POD System |
Applicant |
Penumbra, Inc. |
One Penumbra Place |
Alameda,
CA
94502
|
|
Applicant Contact |
Aditi Kolla |
Correspondent |
Penumbra, Inc. |
One Penumbra Place |
Alameda,
CA
94502
|
|
Correspondent Contact |
Aditi Kolla |
Regulation Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/22/2017 |
Decision Date | 04/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|