FDA 510(k) Application Details - K162524

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K162524
Device Name	Device, Vascular, For Promoting Embolization
Applicant	MicroVention, Inc 1311 Valencia Avenue Tustin, CA 92780 US Other 510(k) Applications for this Company
Contact	Laraine Pangelina Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2016
Decision Date	03/03/2017
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