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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 K190010
Device Name Penumbra System Reperfusion Catheter JET 7
Penumbra, Inc.
One Penumbra Place
alameda,  CA  94502
Applicant Contact micaela victoria
Penumbra, Inc.
One Penumbra Place
alameda,  CA  94502
Correspondent Contact micaela victoria
Regulation Number870.1250
Classification Product Code
Date Received01/03/2019
Decision Date 06/16/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls