Product code OVL

Device name

Hemodialyzer, High Cut-Off

Medical specialty

Unknown

Device class

f

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset