FDA 510(k) Application Details - K000550

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K000550
Device Name	Catheter, Biliary, Diagnostic
Applicant	ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 SANTA CLARA, CA 95052-8167 US Other 510(k) Applications for this Company
Contact	SANDRA SUNDELL 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	02/18/2000
Decision Date	03/17/2000
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