FDA product code MCI: Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
MCI is the FDA product code for graft, vascular, hemodialysis access, synthetic/biological composite. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under MCI reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MCI devices
openFDA lists no recalls for product code MCI.
Frequently asked questions
What is FDA product code MCI?
MCI is the FDA product code for graft, vascular, hemodialysis access, synthetic/biological composite. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is MCI?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MCI
- Run a recall and safety report across every MCI manufacturer
- Watch product code MCI 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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