510(k) K251982

Edwards MC3 Tricuspid annuloplasty ring (4900) by Edwards Lifesciences, LLC — Product Code KRH

K251982 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Edwards MC3 Tricuspid annuloplasty ring (4900)". The FDA issued a decision of Substantially Equivalent on September 23, 2025. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.