510(k) Report

Devices descending from K102129

4 later devices reach Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)20192—
+1K131179Centrimag Primary Console (2ND Generation); Mag MonitorThoratec Corp201301
+2K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Abbott (Formerly Thoratec Corporation)20201—
+3K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical20240—