FDA 510(k) Application Details - K040653

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K040653
Device Name	Catheter, Biliary, Diagnostic
Applicant	EV3 INC 4600 NATHAN LN. NORTH PLYMOUTH, MN 55442-2920 US Other 510(k) Applications for this Company
Contact	MARIA E BRITTLE 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	03/12/2004
Decision Date	04/28/2004
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