FDA 510(k) Application Details - DEN160043

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160043
Device Name	Sentinel Cerebral Protection System
Applicant	Claret Medical, Inc. 1745 Copperhill Parkway, Suite 1 Santa Rosa, CA 95403 US Other 510(k) Applications for this Company
Contact	Zachary Woodson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PUM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2016
Decision Date	06/01/2017
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review