FDA product code MIE: Heart-Valve, Allograft
MIE is the FDA product code for heart-valve, allograft. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MIE reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 80 recalls for MIE devices.
Classification
| Field | Value |
|---|---|
| Device name | Heart-Valve, Allograft |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for MIE devices
80 product recalls in 45 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-01-07.
Frequently asked questions
What is FDA product code MIE?
MIE is the FDA product code for heart-valve, allograft. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MIE?
Class III. Typical premarket route: Contact FDA.
Have MIE devices been recalled?
Yes: 80 product recalls across 45 recall events; the most recent began 2011-01-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MIE
- Run a recall and safety report across every MIE manufacturer
- Watch product code MIE 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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