510(k) Report

Devices descending from K153376

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163531Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation20172—
+1K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…Terumo Cardiovascular Systems Corporation20160—
+2K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2017114
+3K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation20230—