NIEClass II

Catheter, Hemodialysis, Triple Lumen, Non-Implanted

21 CFR 876.5540 / Gastroenterology, Urology

NIE is the FDA product code for Catheter, Hemodialysis, Triple Lumen, Non-Implanted, a class II device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion". As of 2026-09-10, FDA records hold 12 510(k) clearances under this code, the most recent dated 2023-11-16, and 38 recalls.

Classification record

Product code: NIE
Device name: Catheter, Hemodialysis, Triple Lumen, Non-Implanted
FDA definition: Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Regulation: 21 CFR 876.5540
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 12
Ingested recalls: 38

Clearances, product code NIE

By decision year

12 clearances under product code NIE with a decision year between 2002 and 2023, 2015 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NIE by decision year
Year	Clearances
2002	1
2004	1
2009	1
2010	1
2013	1
2014	1
2015	2
2018	1
2019	1
2023	2

Applicants with the most clearances

Product code NIE

Applicants holding the most 510(k) clearances under product code NIE
Applicant	Clearances
C.R. Bard Inc	3
Medical Components, Inc.	3
Medcomp	2
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	1
Covidien, LLC, Formerly Registered AS Tyco Healthca	1
Health Line International Corporation	1
Kendall	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order