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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K212838
Device Name Benchmark Intracranial Access System
Applicant
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Applicant Contact Buu Buu Ly
Correspondent
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Correspondent Contact Buu Buu Ly
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received09/07/2021
Decision Date 05/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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