# MAD: Catheter, Percutaneous (Valvuloplasty)

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- 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)
- 1994: 1
- 1995: 1
- 2002: 1
- 2007: 1
- 2011: 1
- 2018: 1
- 2020: 1
- 2021: 1
- 2024: 2

## Most-cited predicates

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