# K032810: Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Heart Valves
- Decided: Dec 5, 2003 after 87 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: 2 generations back to K893678 (1989). 2 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K980534: Duran Flexible Annuloplasty Ring Model Number H608H, The Heart Valve Div. Medtronic Cardiovascular Surg (1998) Summary page 1.

## Most influential descendants
- K061127: CG Future Annuloplasty System, Model 638R (2006), 1 descendant of its own
- K052970: Simplici-T Annuloplasty System (2006), 1 descendant of its own
- K103812: Mitra-Lift (2011), 0 descendants of its own
- K073324: Medtronic Profile 3D Annuloplasty Ring, Model 680R (2008), 0 descendants of its own

## Indications for use
The Duran Band (Model H607H), Duran Ring and Band (Models 610R and 610B), the Duran AnCore Ring and Band (Models 620R and 620B) and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.

Source page: https://510kreport.com/device/K032810
Methodology: https://510kreport.com/methodology