# NPV: Pulmonary Valve Prosthesis Percutaneously Delivered

- Device class: f; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 3
- Recalls: 2 (2 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: 5
- 2018: 2
- 2019: 4
- 2020: 7
- 2021: 16
- 2022: 26
- 2023: 36
- 2024: 19
- 2025: 22
- 2026: 24

## Most-cited predicates

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