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FDA 510(k) Application Details - K163618
Device Classification Name
More FDA Info for this Device
510(K) Number
K163618
Device Name
INDIGO Aspiration System
Applicant
PENUMBRA, INC.
ONE PENUMBRA PLACE
ALAMEDA, CA 94502 US
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Contact
RICHARD KIMURA
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2016
Decision Date
05/24/2017
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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