510(k) Report

Devices descending from K912554

5 later devices reach Annuloplasty Rings, Model 4400 Mirtal and 4500 Tri through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103520Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC20113—
+1K083623Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC20090—
+2K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.20260—
+2K163608HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc.20171—
+3K171431HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc.20170—