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NIE — Catheter, Hemodialysis, Triple Lumen, Non-Implanted Class II

FDA Device Classification

Classification Details

Product Code
NIE
Device Class
Class II
Regulation Number
876.5540
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232945medical components, inc. (dba medcomp)Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsNovember 16, 2023
K222170health line international corporationPower Acute Triple Lumen Hemodialysis CatheterJanuary 13, 2023
K183219medical components, inc. (dba medcomp)Trio-CT Triple Lumen CatheterJune 14, 2019
K181175medical components, inc. (dba medcomp)12F Tri-Flow Triple Lumen CatheterJuly 5, 2018
K143102arrow international, inc. (subsidiary of teleflex, inc.)Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsJuly 24, 2015
K141531c.r. bardPOWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETERJune 1, 2015
K133456c.r. bardPOWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERSeptember 24, 2014
K123292medcompT3June 11, 2013
K102605covidien, llc, formerly registered as tyco healthcaMAHURKAR TRIPLE LUMEN DIALYSIS CATHETERDecember 22, 2010
K083675c.r. bardPOWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETERMarch 19, 2009
K033570medcompMEDCOMP T-3September 16, 2004
K020089kendallMAHURKAR TRIPLE LUMEN CATHETER, 12 FRApril 10, 2002