510(k) Report

Devices descending from K120586

3 later devices reach Cell Saver Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation20162—
+2K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation20171—
+3K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation20220—