FDA product code MOU: Intravascular Radiation Delivery System
MOU is the FDA product code for intravascular radiation delivery system. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MOU 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 | Intravascular Radiation Delivery System |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MOU devices
openFDA lists no recalls for product code MOU.
Frequently asked questions
What is FDA product code MOU?
MOU is the FDA product code for intravascular radiation delivery system. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MOU?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MOU
- Run a recall and safety report across every MOU manufacturer
- Watch product code MOU 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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