# OAD: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 8
- Recalls: 15 (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: 64
- 2018: 29
- 2019: 39
- 2020: 42
- 2021: 50
- 2022: 20
- 2023: 19
- 2024: 19
- 2025: 19
- 2026: 14

## Most-cited predicates

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