510(k) Report

Devices descending from K081221

10 later devices reach Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083340Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleLevitronix, LLC200891
+2K110493Tandemheart PumpCardiacassist, Inc.201128
+2K102129Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorLevitronix, LLC20104—
+2K093832Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC20100—
+3K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)20192—
+3K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.20191Class I
+3K131179Centrimag Primary Console (2ND Generation); Mag MonitorThoratec Corp201301
+4K232132LifeSPARC SystemCardiacassist, Inc.20230—
+4K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Abbott (Formerly Thoratec Corporation)20201—
+5K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical20240—