# SCZ: Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

- Device class: 2; regulation: 21 CFR 870.1254; FDA's rule: 510(k) required
- FDA decisions: 1
- 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)
- 2024: 1

## Most-cited predicates
- DEN240017: ShortCut (2024), cited by 1

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