# K893678: Duran Flexible Annuloplasty Ring & Obturator H601H

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Blood Systems, Inc.
- Decided: Nov 27, 1989 after 195 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.
6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980534: Duran Flexible Annuloplasty Ring Model Number H608H (1998), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K893678
Methodology: https://510kreport.com/methodology