510(k) Report

Devices descending from K020864

10 later devices reach Edwards MC Tricuspid Annuloplasty System, Model 4900 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLC20250—
+1K103520Carpentier-Edwards Physio Tricuspid Annuloplasty RingEdwards Lifesciences, LLC20113—
+1K101212Medtronic Contour 3D Annuloplasty Ring, Model 690RMedtronic, Inc.20100—
+1K032250Geoform Annuloplasty Ring, Mitral Model 4200Edwards Lifesciences, LLC20033—
+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—
+2K083623Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC20090—
+2K083191Detlogix Annuloplasty Ring, Model: 5100Edwards Lifesciences, LLC20090—
+2K042734SJM Rigid Saddle Ring Model Rsar-(Size)St. Jude Medical, Inc.20040—
+3K171431HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm…Biostable Science & Engineering, Inc.20170—