FDA Product Code KRH: Ring, Annuloplasty

Annuloplasty rings restore mitral valve geometry and competence in mitral regurgitation surgery. FDA product code KRH covers annuloplasty rings used in heart valve repair.

These rigid or flexible rings are sewn to the mitral or tricuspid annulus to reduce annular diameter, restore the normal saddle-shaped geometry, and support the valve leaflets, enabling durable repair of regurgitant valves while preserving native valve tissue.

KRH devices are Class II medical devices, regulated under 21 CFR 870.3800 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Edwards Lifesciences, LLC, Genesee Biomedical, Inc. and Baxter Healthcare Corp.