# DSQ: Ventricular (Assist) Bypass

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 9
- Recalls: 54 (4 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: 36
- 2018: 35
- 2019: 34
- 2020: 48
- 2021: 38
- 2022: 33
- 2023: 48
- 2024: 61
- 2025: 50
- 2026: 46

## Most-cited predicates

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