FDA product code OVL: Hemodialyzer, High Cut-Off
OVL is the FDA product code for hemodialyzer, high cut-off. It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under OVL reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.
Classification
| Field | Value |
|---|---|
| Device name | Hemodialyzer, High Cut-Off |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for OVL devices
openFDA lists no recalls for product code OVL.
Frequently asked questions
What is FDA product code OVL?
OVL is the FDA product code for hemodialyzer, high cut-off. It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is OVL?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OVL
- Run a recall and safety report across every OVL manufacturer
- Watch product code OVL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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