510(k) Report

Devices descending from K160197

2 later devices reach Haemonetics Cell Saver Elite Autotransfusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation20171—
+2K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation20220—