# MAF: Stent, Coronary

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 21
- Recalls: 21 (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: 35
- 2018: 32
- 2019: 25
- 2020: 21
- 2021: 13
- 2022: 8
- 2023: 8
- 2024: 3
- 2025: 2
- 2026: 4

## Most-cited predicates
- P900043/S024: BX Velocity (TM) with Hepacoat (TM) on Raptor (TM) Stent System for Coronary Arteries (2000), cited by 2
- P900043: Palmaz-Schatz (TM) Balloon Expandable Stent (1994), cited by 1

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