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 and Abbott Medical.
List of Ring, Annuloplasty devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Ring, Annuloplasty devices (product code KRH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →