# MAL: Graft, Vascular, Synthetic/Biologic Composite

- Device class: 2; regulation: 21 CFR 870.3450; FDA's rule: 510(k) required
- FDA decisions: 8
- Recalls: 5 (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)
- 1993: 2
- 1994: 2
- 1995: 2
- 1996: 1
- 2002: 1
- 2005: 1
- 2010: 1
- 2011: 1
- 2012: 1

## Most-cited predicates
- K954848: Hemashield Microvel Velour Knitted Vascular Graft (1996), cited by 2
- P890045: Gelseal TM Triaxial Vascular Graft (1993), cited by 1
- K021213: Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts (2002), cited by 1
- K052302: Hemashield Platinum Woven Double Velour Taaa Graft Configuration (2005), cited by 1
- P890045/S001: Vascutek Gelsoft (TM) Vascular Graft (1995), cited by 1

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