510(k) Report

Devices descending from K143609

1 later device reach Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180086Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc.2018013