# MGB: Device, Hemostasis, Vascular

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 19
- Recalls: 7 (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)
- 2017: 15
- 2018: 23
- 2019: 27
- 2020: 10
- 2021: 17
- 2022: 11
- 2023: 18
- 2024: 22
- 2025: 18
- 2026: 24

## Most-cited predicates
- P010049: Quickseal Femoral Arterial Closure System (2002), cited by 1

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