FDA 510(k) Application Details - K032436

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K032436
Device Name	Catheter, Biliary, Diagnostic
Applicant	AVANTEC VASCULAR CORP. 1049 KIEL CT. SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	JAMES M SHY 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	08/07/2003
Decision Date	02/04/2004
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