Device Classification Name |
catheter, thrombus retriever
|
510(k) Number |
K152541 |
Device Name |
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters |
Applicant |
PENUMBRA, INC. |
ONE PENUMBRA PLACE |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
MICHAELA MAHL |
Correspondent |
PENUMBRA, INC. |
ONE PENUMBRA PLACE |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
MICHAELA MAHL |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/04/2015 |
Decision Date | 01/13/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|