510(k) Report

Devices descending from K161815

2 later devices reach FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.20241—
+2K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.20250—