# QZI: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 6
- Recalls: 4 (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)
- 2023: 1
- 2024: 16
- 2025: 40
- 2026: 49

## Most-cited predicates

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