510(k) Report

Devices descending from K163531

2 later devices reach Advanced Perfusion System 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2017114
+2K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation20230—