FDA 510(k) Application Details - K140151

Device Classification Name	More FDA Info for this Device
510(K) Number	K140151
Device Name	EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
Applicant	BTG INTERNATIONAL, INC. 11911 NORTH CREEK PARKWAY S BOTHELL, WA 98011 US Other 510(k) Applications for this Company
Contact	JOCELYN KERSTEN 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	01/22/2014
Decision Date	05/21/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review