# K980534: Duran Flexible Annuloplasty Ring Model Number H608H

- Pathway: 510(k) (Traditional)
- Applicant: The Heart Valve Div. Medtronic Cardiovascular Surg
- Decided: Apr 30, 1998 after 78 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: 1 generation back to K893678 (1989). 1 ancestor in all.
5 later devices descend 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)
- K893678: Duran Flexible Annuloplasty Ring & Obturator H601H, Medtronic Blood Systems, Inc. (1989) Summary page 1.

## Most influential descendants
- K032810: Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore (2003), 4 descendants of its own
- 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 Flexible Annuloplasty Ring is indicated for the reconstruction and/or remodeling of the pathologic mitral and tricuspid valves. Combined atrioventricular valve insufficiency and stenosis may be corrected by appropriate commissurotomy and valvular remodeling.

Source page: https://510kreport.com/device/K980534
Methodology: https://510kreport.com/methodology