510(k) K251688

Carpentier-Edwards Physio Annuloplasty Ring (4450) by Edwards Lifesciences, LLC — Product Code KRH

K251688 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Carpentier-Edwards Physio Annuloplasty Ring (4450)". The FDA issued a decision of Substantially Equivalent on September 17, 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.