FDA product code PYR: Neuraxial Administration Set - Intrathecal Delivery
PYR is the FDA product code for neuraxial administration set - intrathecal delivery. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. Devices under PYR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Neuraxial Administration Sets used to deliver fluids to the intrathecal space.
Classification
| Field | Value |
|---|---|
| Device name | Neuraxial Administration Set - Intrathecal Delivery |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for PYR devices
openFDA lists no recalls for product code PYR.
Frequently asked questions
What is FDA product code PYR?
PYR is the FDA product code for neuraxial administration set - intrathecal delivery. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is PYR?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PYR
- Run a recall and safety report across every PYR manufacturer
- Watch product code PYR 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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