# PSQ: Intracardiac Patch Or Pledget, Biologically Derived

- Device class: 2; regulation: 21 CFR 870.3470; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 195 days (middle half 195–257)
- Recalls: 2 (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: 3
- 2018: 1
- 2019: 2
- 2020: 2
- 2021: 1
- 2022: 2

## Most-cited predicates
- K172085: PhotoFix Decellularized Bovine Pericardium (2017), cited by 1
- K181038: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) (2018), cited by 1

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