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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 K211654
FOIA Releasable 510(k) K211654
Device Name Penumbra System (Reperfusion Catheter RED 72)
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  95132
Applicant Contact Nikita Patel
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  95132
Correspondent Contact Nikita Patel
Regulation Number870.1250
Classification Product Code
NRY  
Date Received05/28/2021
Decision Date 08/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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