# K061127: CG Future Annuloplasty System, Model 638R

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: May 23, 2006 after 29 days
- Product code: KRH (Ring, Annuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K893678 (1989). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052860: CG Future Annuloplasty Band, Medtronic Heart Valves (2005) Summary page 1.
- K032810: Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore, Medtronic Heart Valves (2003) Summary page 1.

## Most influential descendants
- K073324: Medtronic Profile 3D Annuloplasty Ring, Model 680R (2008), 0 descendants of its own

## Indications for use
The CG Future® Annuloplasty Ring and Band is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Source page: https://510kreport.com/device/K061127
Methodology: https://510kreport.com/methodology