# LFJ: Catheter, Subclavian

- Device class: 2; regulation: 21 CFR 876.5540; FDA's rule: 510(k) required
- FDA decisions: 65
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1985: 6
- 1986: 3
- 1987: 5
- 1988: 8
- 1989: 6
- 1990: 9
- 1991: 2
- 1992: 1
- 1993: 2
- 1994: 6

## Most-cited predicates
- K895417: Arrow Large-Bore Dual Lumen Hemodialysis Kit (1990), cited by 2
- K871488: Vas-Cath Permanent Dual Lumen Hemodialysis Cath (1987), cited by 2
- K893439: Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C (1989), cited by 2
- K881743: Vas-Cath Flexxicon Dual Lumen Dialysis Catheter (1988), cited by 1
- K871749: Adult Perm-Cath 40CM. (1987), cited by 1
- K914162: Vas-Cath Flexxicon 2 Dual Lumen Dialysis Catheters (1993), cited by 1
- K925819: AKCESS0CATH Kit (1994), cited by 1
- K821684: MCSCP8PS with 'Y' Hub (1982), cited by 1
- K913468: Uldall Double Lumen Hemodialysis Catheter Set/Tray (1994), cited by 1

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