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FDA 510(k) Application Details - K113163
Device Classification Name
Catheter, Thrombus Retriever
More FDA Info for this Device
510(K) Number
K113163
Device Name
Catheter, Thrombus Retriever
Applicant
PENUMBRA, INC.
1351 HARBOR BAY PARKWAY
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
10/26/2011
Decision Date
11/23/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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