FDA product code PDI: Beta 2-Microglobulin Apheresis Column
PDI is the FDA product code for beta 2-microglobulin apheresis column. It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under PDI reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).
Classification
| Field | Value |
|---|---|
| Device name | Beta 2-Microglobulin Apheresis Column |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PDI devices
openFDA lists no recalls for product code PDI.
Frequently asked questions
What is FDA product code PDI?
PDI is the FDA product code for beta 2-microglobulin apheresis column. It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is PDI?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PDI
- Run a recall and safety report across every PDI manufacturer
- Watch product code PDI 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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