OVL — Hemodialyzer, High Cut-Off Class f
FDA product code OVL covers "Hemodialyzer, High Cut-Off", a Class f medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OVL
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- No
Definition
Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.