FDA product code SEU: Peripheral Temporary And Retrievable Stent System
SEU is the FDA product code for peripheral temporary and retrievable stent system. It is a Class II device, regulated under 21 CFR 870.5110 and reviewed by the Cardiovascular panel. Devices under SEU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.
Classification
| Field | Value |
|---|---|
| Device name | Peripheral Temporary And Retrievable Stent System |
| Device class | Class II |
| Regulation | 21 CFR 870.5110 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for SEU devices
openFDA lists no recalls for product code SEU.
Frequently asked questions
What is FDA product code SEU?
SEU is the FDA product code for peripheral temporary and retrievable stent system. It is a Class II device, regulated under 21 CFR 870.5110 and reviewed by the Cardiovascular panel.
What device class is SEU?
Class II, regulation 21 CFR 870.5110. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SEU
- Run a recall and safety report across every SEU manufacturer
- Watch product code SEU 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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