Device Classification Name |
catheter, thrombus retriever
|
510(k) Number |
K160449 |
FOIA Releasable 510(k) |
K160449
|
Device Name |
Penumbra System, Penumbra Pump MAX |
Applicant |
PENUMBRA, INC. |
ONE PENUMBRA PLACE |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
RICHARD KIMURA |
Correspondent |
PENUMBRA, INC. |
ONE PENUMBRA PLACE |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
RICHARD KIMURA |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/18/2016 |
Decision Date | 05/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|