510(k) K230318

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring by Corcym S.r.l. — Product Code KRH

K230318 is an FDA 510(k) premarket notification submitted by Corcym S.r.l. for the device "Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring". The FDA issued a decision of Substantially Equivalent on April 7, 2023. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Corcym S.r.l. has at least 2 other 510(k) clearances on record.