FDA 510(k) Application Details - K222358

Device Classification Name	More FDA Info for this Device
510(K) Number	K222358
Device Name	Indigo Aspiration System - Lightning Flash
Applicant	Penumbra, Inc. One Penumbra Place Alameda, CA 95132 US Other 510(k) Applications for this Company
Contact	Deanna Kimlinger 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	08/04/2022
Decision Date	12/20/2022
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