FDA 510(k) Application Details - K213314

Device Classification Name	More FDA Info for this Device
510(K) Number	K213314
Device Name	CerusEndo Microcatheter (027)
Applicant	Cerus Endovascular, Inc. 47757 Fremont Blvd Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Lori Adels Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2021
Decision Date	03/15/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review