FDA 510(k) Application Details - K191119

Device Classification Name	More FDA Info for this Device
510(K) Number	K191119
Device Name	EkoSonic Endovascular Device
Applicant	BTG International, Inc. 11911 North Creek Parkway S Bothell, WA 98011 US Other 510(k) Applications for this Company
Contact	Joshua Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2019
Decision Date	08/23/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review