# NCA: Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

- Device class: 2; regulation: 21 CFR 878.4300; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2001: 2
- 2002: 1

## Most-cited predicates
- K013664: Coalescent Surgical U-Clip (2002), cited by 9
- K003446: Symmetry Aortic Clip System (2001), cited by 3
- K011589: Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to 4.0 MM Outer Diameter Vessels), M (2001), cited by 1

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