NIE

Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Product code

NIE

Device name

Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Device class

Class 2

21 CFR

21 CFR 876.5540

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

12 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-11-16.

1 summaries are archived here for direct download.