510(k) Report

Devices descending from K831949

4 later devices reach Prosthetic Rings #4400 Mitral & 4500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083191Detlogix Annuloplasty Ring, Model: 5100Edwards Lifesciences, LLC20090—
+1K032250Geoform Annuloplasty Ring, Mitral Model 4200Edwards Lifesciences, LLC20033—
+2K083623Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100Edwards Lifesciences, LLC20090—
+2K042734SJM Rigid Saddle Ring Model Rsar-(Size)St. Jude Medical, Inc.20040—