FDA 510(k) Application Details - K111627

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K111627
Device Name	Catheter, Biliary, Diagnostic
Applicant	IDEV TECHNOLOGIES, INC. 253 MEDICAL CENTER BLVD WEBSTER, TX 77598 US Other 510(k) Applications for this Company
Contact	DARLENE GARNER 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	06/10/2011
Decision Date	08/21/2012
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