# K011395: Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638B

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Jul 12, 2001 after 66 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052860: CG Future Annuloplasty Band (2005), 3 descendants of its own
- K061127: CG Future Annuloplasty System, Model 638R (2006), 1 descendant of its own
- K070488: Micardia Annuloplasty Band DR (2008), 0 descendants of its own
- K073324: Medtronic Profile 3D Annuloplasty Ring, Model 680R (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K011395
Methodology: https://510kreport.com/methodology