# MIH: System, Endovascular Graft, Aortic Aneurysm Treatment

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 21
- Recalls: 161 (7 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: 41
- 2018: 39
- 2019: 34
- 2020: 44
- 2021: 50
- 2022: 49
- 2023: 50
- 2024: 62
- 2025: 50
- 2026: 35

## Most-cited predicates
- P040002: Endologix Powerlink System (2004), cited by 1

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