FDA 510(k) Application Details - K061235

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K061235
Device Name	Catheter, Biliary, Diagnostic
Applicant	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	KEVIN DRISKO Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2006
Decision Date	06/05/2006
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review