# MFX: Vessel Guard Or Cover, To Facilitate Revision Surgeries

- Device class: 2; regulation: 21 CFR 870.3470; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 0 (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)
- 1996: 1
- 2006: 1

## Most-cited predicates
- K061727: Gore Preclude Vessel Guard (2006), cited by 4
- K960532: Preclude Ima Sleeve (1996), cited by 3

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