FDA 510(k) Application Details - K163458

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K163458
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	C.R BARD. INC. 605 NORTH 5600 WEST SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	SILVIA DE LA BARRA Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2016
Decision Date	04/04/2017
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