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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, embolectomy
510(k) Number K121917
Device Name PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
Original Applicant
PENUMBRA, INC.
1351 harbor bay parkway
alameda,  CA  94502
Original Contact michaela mahl
Regulation Number870.5150
Classification Product Code
DXE  
Date Received07/02/2012
Decision Date 09/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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