510(k) Report

Devices descending from K974630

1 later device reach 72 Hour Use Trach Care with Microban through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031997Mallinckrodt Dar TY-Care / TY-Care Exel Closed Suction SystemMallinckrodt Dar S.R.L.20030—