SEU
- Product code
- SEU
- Device name
- Peripheral Temporary And Retrievable Stent System
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5110
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN240048 | 2025-05-29 | Reflow Medical, Inc. | Spur Peripheral Retrievable Stent System | — |
Official FDA classification page: SEU
Classification and pathway per current FDA publications. Data from openFDA (CC0).