Device Classification Name |
catheter, thrombus retriever
|
510(k) Number |
K113163 |
Device Name |
PENUMBRA SYSTEM MAX |
Applicant |
PENUMBRA, INC. |
1351 HARBOR BAY PARKWAY |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
SETH SCHULMAN |
Correspondent |
PENUMBRA, INC. |
1351 HARBOR BAY PARKWAY |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
SETH SCHULMAN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/26/2011 |
Decision Date | 11/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|