Device Classification Name |
Catheter, Percutaneous, Neurovasculature
|
510(k) Number |
K221822 |
Device Name |
BENCHMARK BMX81 Access System |
Applicant |
Penumbra, Inc |
One Penumbra Place |
Alameda,
CA
95132
|
|
Applicant Contact |
Sindokht (Sisi) Soltanzadeh |
Correspondent |
Penumbra, Inc |
One Penumbra Place |
Alameda,
CA
95132
|
|
Correspondent Contact |
Sindokht Soltanzadeh |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/23/2022 |
Decision Date | 11/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|