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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 K211411
Device Name Penumbra System (RED 68 Reperfusion Catheter)
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  95132
Applicant Contact Micaela Victoria
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  95132
Correspondent Contact Micaela Victoria
Regulation Number870.1250
Classification Product Code
NRY  
Date Received05/06/2021
Decision Date 07/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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