# DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

- Device class: 2; regulation: 21 CFR 870.3450; FDA's rule: 510(k) required
- FDA decisions: 189
- 510(k) review time 2021–2025: median 155 days (middle half 51–210)
- Recalls: 14 (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: 3
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 2
- 2022: 2
- 2023: 2
- 2024: 5
- 2025: 2
- 2026: 1

## Most-cited predicates
- K071778: Hero Vascular Access Device (2008), cited by 4
- K933590: Baxter Reinforced Expanded Ptfe Vascular Graft (1994), cited by 4
- K952293: Vascutek Gelweave Vascular Graft (1995), cited by 4
- K062161: Gore Propaten Vascular Graft (2006), cited by 4
- K983861: Distaflo Bypass Graft (1998), cited by 3
- K091491: Hero Vascular Access Device (2009), cited by 3
- K083169: Eptfe Slftm Spiral Vascular Graft (2009), cited by 3
- K962433: Meadox Exxcel Eptfe Vascular Graft (1997), cited by 3
- K032900: Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts (2003), cited by 2
- K821716: Bard Ptfe Vascular Prosthesis (1982), cited by 2

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