FDA 510(k) Application Details - K073166

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K073166
Device Name	Catheter, Continuous Flush
Applicant	EKOS CORP. 11911 N 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	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2007
Decision Date	04/22/2008
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review