FDA 510(k) Application Details - K063532

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K063532
Device Name	Catheter, Biliary, Diagnostic
Applicant	BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 TEMPE, AZ 85280-1740 US Other 510(k) Applications for this Company
Contact	LINDSAY K PACK 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	11/22/2006
Decision Date	05/30/2008
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review