FDA 510(k) Application Details - K183361

Device Classification Name	More FDA Info for this Device
510(K) Number	K183361
Device Name	EkoSonic Endovascular Device with Control Unit 4.0
Applicant	BTG International, Inc. 11911 N Creek Pkwy S Bothell, WA 98011 US Other 510(k) Applications for this Company
Contact	Benjamin Hornsey 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	12/04/2018
Decision Date	04/05/2019
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