FDA 510(k) Application Details - K241399

Device Classification Name	More FDA Info for this Device
510(K) Number	K241399
Device Name	Indigo« Lightning Flash Aspiration System û Select +Ö Catheter
Applicant	Penumbra, Inc. One Penumbra Place Alameda, CA 94502 US Other 510(k) Applications for this Company
Contact	Samyukta Rangachari 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	05/16/2024
Decision Date	06/10/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review