# K023940: Shelhigh Bioring

- Pathway: 510(k) (Traditional)
- Applicant: Shelhigh, Inc.
- Decided: Jun 4, 2003 after 190 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.
No later device cites it as a predicate yet.
0 of 1 device 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) AnnuloFlex: named in the summary without a submission number
- (no number) Duran Flexiable Ring: named in the summary without a submission number
- (no number) Shelhigh No-React pericardial Patch: named in the summary without a submission number

## Indications for use
The Shelhigh BioRingTM is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.

Source page: https://510kreport.com/device/K023940
Methodology: https://510kreport.com/methodology