Device Classification Name |
catheter, thrombus retriever
|
510(k) Number |
K161640 |
FOIA Releasable 510(k) |
K161640
|
Device Name |
Penumbra System ACE 68 Reperfusion Catheter |
Applicant |
Penumbra, Inc. |
One Penumbra Place |
Alameda,
CA
94502
|
|
Applicant Contact |
Charles DeNault |
Correspondent |
Penumbra, Inc. |
One Penumbra Place |
Alameda,
CA
94502
|
|
Correspondent Contact |
Charles DeNault |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/14/2016 |
Decision Date | 07/12/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|