510(k) K103520

CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING by Edwards Lifesciences, LLC — Product Code KRH

K103520 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING". The FDA issued a decision of Substantially Equivalent on June 24, 2011. 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.