OVL

Hemodialyzer, High Cut-Off

Product code: OVL
Device name: Hemodialyzer, High Cut-Off
Device class: Class F
Medical specialty: Unknown
Marketing pathway: HDE - Humanitarian Device Exemption

FDA classification definition

Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.

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

Official FDA classification page: OVL

Classification and pathway per current FDA publications. Data from openFDA (CC0).