# NIU: Stent, Superficial Femoral Artery, Drug-Eluting

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 4
- 2018: 10
- 2019: 20
- 2020: 22
- 2021: 9
- 2022: 5
- 2023: 7
- 2024: 7
- 2025: 4
- 2026: 4

## Most-cited predicates

Source page: https://510kreport.com/product-code/NIU
Data by year (CSV): https://510kreport.com/product-code/NIU.csv