Device Classification Name |
catheter, thrombus retriever
|
510(k) Number |
K072718 |
Device Name |
PENUMBRA SYSTEM |
Applicant |
PENUMBRA, INC. |
2401 MERCED ST., SUITE 200 |
SAN LEANDRO,
CA
94577
|
|
Applicant Contact |
THERESA BRANDNER-ALLEN |
Correspondent |
PENUMBRA, INC. |
2401 MERCED ST., SUITE 200 |
SAN LEANDRO,
CA
94577
|
|
Correspondent Contact |
THERESA BRANDNER-ALLEN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/25/2007 |
Decision Date | 12/28/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|