# LFK: Catheter, Femoral

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 16
- Recalls: 6 (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)
- 1982: 1
- 1983: 2
- 1986: 3
- 1987: 2
- 1988: 2
- 1989: 3
- 1992: 2
- 1997: 1

## Most-cited predicates
- K914936: Continuous Arteriovenous Hemofiltration Cath Set (1992), cited by 1

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