FDA 510(k) Application Details - K111705

Device Classification Name	More FDA Info for this Device
510(K) Number	K111705
Device Name	EKOSONIC ENDOVASCULAR SYSTEM
Applicant	EKOS CORPORATION 11911 North Creek Parkway South 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	06/17/2011
Decision Date	08/03/2011
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