510(k) Report

Devices descending from K131041

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151349Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation20155—
+2K153376Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation201542
+3K163531Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation20172—
+3K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…Terumo Cardiovascular Systems Corporation20160—
+4K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2017114
+5K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation20230—