FDA 510(k) Application Details - K121917

Device Classification Name	More FDA Info for this Device
510(K) Number	K121917
Device Name	PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
Applicant	PENUMBRA, INC. 1351 HARBOR BAY PARKWAY ALAMEDA, CA 94502 US Other 510(k) Applications for this Company
Contact	MICHAELA MAHL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2012
Decision Date	09/19/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review