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FDA 510(k) Application Details - K133317
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K133317
Device Name
Catheter, Thrombus Retriever
Applicant
PENUMBRA, INC.
1351 HARBOR BAY PKWY.
ALAMEDA, CA 94502 US
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Contact
SETH SCHULMAN
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Regulation Number
870.1250
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Classification Product Code
NRY
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More FDA Info for this Product Code
Date Received
10/28/2013
Decision Date
05/13/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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