FDA 510(k) Application Details - K002143

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K002143
Device Name	Catheter, Biliary, Diagnostic
Applicant	GUIDANT CORP. 3200 LAKESIDE DR. SANTA CLARA, CA 95054-2807 US Other 510(k) Applications for this Company
Contact	SUSAN SILAVIN, PH.D. 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	07/17/2000
Decision Date	10/12/2000
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