FDA 510(k) Application Details - K133924

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K133924
Device Name	Device, Vascular, For Promoting Embolization
Applicant	ARTVENTIVE MEDICAL GROUP, INC 24125 85TH AVENUE SE WOODINVILLE, WA 98072 US Other 510(k) Applications for this Company
Contact	Roberta Hines 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	12/23/2013
Decision Date	12/03/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review