# DYF: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

- Device class: 2; regulation: 21 CFR 870.3450; FDA's rule: 510(k) required
- FDA decisions: 21
- 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)
- 1992: 1
- 1993: 1
- 1994: 2
- 1995: 2
- 1996: 1
- 1997: 2
- 1998: 2
- 1999: 4
- 2000: 1
- 2001: 1

## Most-cited predicates
- K791810: Vascular Graft Prost. of Expanded Ptfe (1979), cited by 5
- K991683: Ptfe Ringed Gore-Tex Vascular Graft (1999), cited by 2
- K944844: Baxter Reinforced Expanded Ptfe Stepped Vascular Graft (1995), cited by 2
- K842144: Gore-Tex Vascular Graft, Fep-Ringed (1984), cited by 1
- K992958: Advanta Graft (<6MM) (1999), cited by 1
- K960766: Meadox Medicals, Inc. Expanded Ptfe Vascular Graft (1997), cited by 1
- K924360: Impra Flex Grafts (Various Product Code Numbers) (1992), cited by 1

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