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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K142458
FOIA Releasable 510(k) K142458
Device Name Penumbra System ACE
Applicant
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Applicant Contact Michaela Mahl
Correspondent
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Correspondent Contact Michaela Mahl
Regulation Number870.1250
Classification Product Code
NRY  
Date Received09/02/2014
Decision Date 05/22/2015
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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