FDA 510(k) Application Details - K180412

Device Classification Name	More FDA Info for this Device
510(K) Number	K180412
Device Name	Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
Applicant	Penumbra, Inc. One Penumbra Place Alameda, CA 94502 US Other 510(k) Applications for this Company
Contact	Richard Kimura 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	02/15/2018
Decision Date	05/15/2018
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