510(k) Report

Devices descending from K021051

5 later devices reach Annuloflo System, Mitral Model AR700 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071327Memo 3D Semirigid Annuloplasty RingSorin Biomedica Cardio S.R.L.20074—
+2K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…Corcym S.r.l.20231—
+2K142221MEMO 3D ReChordSorin Group Italia S.R.L.20143—
+3K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.20260—
+3K180411MEMO 4DSorin Group Italia S.R.L.20182—