# K961246: SJM Seguin Annuloplasty Ring Model Sar-M

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Inc.
- Decided: Feb 14, 1997 after 319 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Carpentier-Edwards Physio™ annuloplasty ring: named in the summary without a submission number

## Most influential descendants
- K014037: SJM Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size) (2002), 2 descendants of its own
- K092310: Seguin Annuloplasty Ring (2009), 1 descendant of its own
- K253232: Seguin Annuloplasty Ring (2025), 0 descendants of its own

## Indications for use
The Seguin Annuloplasty Ring is indicated for use in repair of diseased or damaged mitral heart valves that are determined by the Physician to be repairable and do not require replacement. The Seguin Annuloplasty Ring provides support to the mitral heart valve restricting expansion of the annulus.

Source page: https://510kreport.com/device/K961246
Methodology: https://510kreport.com/methodology