FDA 510(k) Application Details - K181051

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K181051
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Shape Memory Medical 807 Aldo Avenue, Suite 109 Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Meghan Reu 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	04/20/2018
Decision Date	06/22/2018
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