# LPC: Device, Angioplasty, Laser, Coronary

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 3
- Recalls: 3 (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: 10
- 2018: 8
- 2019: 2
- 2020: 1
- 2021: 2
- 2022: 4
- 2023: 4
- 2024: 2
- 2025: 1
- 2026: 3

## Most-cited predicates
- P910001: Spectranectics CVX-300 Excimer Laser System (1993), cited by 1

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