510(k) K192762

Physio Flex Annuloplasty Ring by Edwards Lifesciences, LLC — Product Code KRH

K192762 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Physio Flex Annuloplasty Ring". The FDA issued a decision of Substantially Equivalent on December 16, 2019. 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.