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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
Model MULTIPLE
Device Name PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
Applicant
PENUMBRA, INC.
1351 harbor bay parkway
alameda,  CA  94502
Contact michaela mahl
Regulation Number870.5150
Classification Product Code
DXE  
Date Received07/02/2012
Decision Date 09/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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