FDA 510(k) Application Details - K171845

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K171845
Device Name	Device, Vascular, For Promoting Embolization
Applicant	EMBA Medical Limited 3451 Commerce Pkwy Miramar, FL 33025 US Other 510(k) Applications for this Company
Contact	Veronica Reott 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	06/20/2017
Decision Date	08/18/2017
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