QIR

Pediatric Hemodialysis System

Product code

QIR

Device name

Pediatric Hemodialysis System

Device class

Class 2

21 CFR

21 CFR 876.5861

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

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

FDA classification definition

For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.

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