FDA 510(k) Applications for Medical Device Product Code "NIE"
(Catheter, Hemodialysis, Triple Lumen, Non-Implanted)

FDA 510(k) Number Applicant Device Name Decision Date
K143102 Arrow International, Inc. (Subsidiary of Teleflex Inc.) Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions 07/24/2015
K133456 C.R. BARD, INC. POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER 09/24/2014
K141531 C.R. BARD, INC. POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER 06/01/2015
K083675 C.R. BARD, INC. POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER 03/19/2009
K102605 COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER 12/22/2010
K033570 MEDCOMP MEDCOMP T-3 09/16/2004
K123292 MEDCOMP T3 06/11/2013
K181175 Medical Components Inc. (Dba Medcomp) 12F Tri-Flow Triple Lumen Catheter 07/05/2018
K020089 THE KENDALL COMPANY MAHURKAR TRIPLE LUMEN CATHETER, 12 FR 04/10/2002


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