FDA 510(k) Application Details - K133456

Device Classification Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted   More FDA Info for this Device
510(K) Number	K133456
Device Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Applicant	C.R. BARD, INC. 605 N 5600 W SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	ELIZABETH PETERSON Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2013
Decision Date	09/24/2014
Decision	SEKD - SUBST EQUIV - KIT WITH DRUGS
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