510(k) Report

Devices descending from K951368

3 later devices reach Carbomedics Exended Mitral Rotator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery)19980—
+1K974648Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc.19980—
+1K960923Carbomedics Mitral RotatorCarbomedics, Inc.19960—