510(k) Report

Devices descending from K971520

7 later devices reach S3 Cyclic RPM Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071318Modification to: Stockert S5 SystemSorin Group Deutschland GmbH2007513
+1K042374Stockert SCP RhythmStockert Instrumente GmbH20046—
+2K210130Stockert S5 SystemLivanova Deutschland, GmbH20212—
+2K112225Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH201124
+2K082344Stockert S5 System, Stockert Electrical Venous Occluder (Evo)Sorin Group Deutschland GmbH200821
+3K221373Essenz HLMLivanova Deutschland, GmbH20231—
+4K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH202301