# K253232: Seguin Annuloplasty Ring

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Oct 29, 2025 after 30 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 K961246 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092310: Seguin Annuloplasty Ring, St Jude Medical (2009) Summary page 5.

## Indications for use
The Seguin Annuloplasty Ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.

Source page: https://510kreport.com/device/K253232
Methodology: https://510kreport.com/methodology