NYU

Catheter, Hemodialysis, Implanted, Coated

Product code

NYU

Device name

Catheter, Hemodialysis, Implanted, Coated

Device class

Class 2

21 CFR

21 CFR 876.5540

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Implant

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

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

FDA classification definition

Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.

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