# PST: Aortic Annuloplasty Ring

- Device class: 2; regulation: 21 CFR 870.3800; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2017: 2

## Most-cited predicates
- K163608: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (2017), cited by 1

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