FDA product code MIR: Shunt, Portosystemic, Endoprosthesis
MIR is the FDA product code for shunt, portosystemic, endoprosthesis. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MIR reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Shunt, Portosystemic, Endoprosthesis |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MIR devices
openFDA lists no recalls for product code MIR.
Frequently asked questions
What is FDA product code MIR?
MIR is the FDA product code for shunt, portosystemic, endoprosthesis. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MIR?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MIR
- Run a recall and safety report across every MIR manufacturer
- Watch product code MIR 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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