FDA 510(k) Application Details - K130981

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K130981
Device Name	Catheter, Biliary, Diagnostic
Applicant	CORDIS CORP. 6500 PASEO PADRE PARKWAY FREMONT, CA 94555 US Other 510(k) Applications for this Company
Contact	KIM FONDA 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	04/09/2013
Decision Date	03/12/2014
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review