510(k) Report

Devices descending from K941921

22 later devices reach Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC200321Class I
+2K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)20192—
+2K131179Centrimag Primary Console (2ND Generation); Mag MonitorThoratec Corp201301
+2K110493Tandemheart PumpCardiacassist, Inc.201128
+2K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+2K102129Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorLevitronix, LLC20104—
+2K090051Levitronix Pedimag Blood Pump, Model 201-90052Levitronix, LLC200921
+2K073631Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation20080—
+2K081221Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleLevitronix, LLC200810—
+2K053630Levitronix Centrimag Primary ConsoleLevitronix, LLC200611—
+2K051209Levitronix Centrimag Back-UP ConsoleLevitronix, LLC200521
+3K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion…Qura S.R.L20231—
+3K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Abbott (Formerly Thoratec Corporation)20201—
+3K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.20191Class I
+3K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+3K090004Levitronix, Thoratec Centrimag Back-UP ConsolesLevitronix, LLC200911
+3K083340Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleLevitronix, LLC200891
+4K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.20250—
+4K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical20240—
+4K232132LifeSPARC SystemCardiacassist, Inc.20230—
+4K093832Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC20100—