# ONU: Drug-Eluting Peripheral Transluminal Angioplasty Catheter

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 6
- Recalls: 1 (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: 14
- 2018: 12
- 2019: 15
- 2020: 16
- 2021: 21
- 2022: 20
- 2023: 20
- 2024: 23
- 2025: 18
- 2026: 14

## Most-cited predicates

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