FDA 510(k) Application Details - K161367

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K161367
Device Name	Device, Neurovascular Embolization
Applicant	MICROVENTION, INC. 1311 VALENCIA AVENUE TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	SAPNA SINGH Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2016
Decision Date	08/31/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review