Hemodialyzer, High Cut-Off

OVL · f · Unknown

Classification

FDA Product Code: OVL
Device class: f
Regulation: —
Review panel: GU
Medical specialty: Unknown
Submission type: 6
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown