# NFA: Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 22
- Recalls: 4 (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)
- 2001: 1
- 2002: 3
- 2003: 3
- 2004: 1
- 2005: 3
- 2006: 8
- 2007: 1
- 2008: 2

## Most-cited predicates
- K032884: Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath (2004), cited by 7
- K013913: Percusurge Guardwire Plus Temporary Occlusion and Aspiration System (2002), cited by 6
- K023691: Boston Scientific Filterwire EX Embolic (2003), cited by 4
- K023878: Guardwire Temporary Occlusion and Aspiration System (2003), cited by 4
- K003992: Percusurge Guardwire Temporary Occlusion and Aspiration System (2001), cited by 3
- K063785: Spiderfx Embolic Protection Device (2007), cited by 2
- K061332: Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM) (2006), cited by 2
- K030201: Modification to Export Aspiration Catheter (2003), cited by 2
- K060651: Proxis System, Model EPS101 (2006), cited by 2
- K014223: Modification to Guardwire Plus Temporary Occlusion & Aspiration System (2002), cited by 2

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