510(k) Report

Devices descending from K203609

4 later devices reach Intravascular Administration Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243529Solution Administration SetsBaxter Healthcare Corporation20250Class I
+1K221121Volumat Polyethylene I.V. Administration SetFresenius Kabi20230—
+1K220301Volumat LineFresenius Kabi20230—
+1K220312Polyfusion IV Administration SetsPoly Medicure Limited20230—