510(k) Report

Devices descending from K973011

48 later devices reach BPX80 Bio-Pump (BPX80) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC202032
+1K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+1K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc.20117—
+1K100631Affiity CP Centrifugal Blood PumpMedtronic, Inc.20109—
+1K080774Capiox SP Pump (with or Without X-Coating)Terumo Cardiovascular Systems Corp.20080—
+1K050109Trillium Biopump Plus, Model BPX80TMedtronic Perfusion Systems20056—
+1K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC200321Class I
+1K020529Large Centrifugal Blood Pump, Model CP-2A-Med Systems, Inc.20020—
+1K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc.200013—
+1K992592A-Miniature Centrifugal Blood Pump System, Model CPB 2000A-Med Systems, Inc.20002—
+2K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+2K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+2K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)20192—
+2K132712Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP AdapterMedtronic, Inc.20130—
+2K131179Centrimag Primary Console (2ND Generation); Mag MonitorThoratec Corp201301
+2K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+2K110493Tandemheart PumpCardiacassist, Inc.201128
+2K111657Affinity CP Centrifugal Blood Pump with Balance BiosurfaceMedtronic, Inc.20111—
+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—
+2K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+2K061369Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc.20064—
+2K053630Levitronix Centrimag Primary ConsoleLevitronix, LLC200611—
+2K051209Levitronix Centrimag Back-UP ConsoleLevitronix, LLC200521
+2K013393Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1HA-Med Systems, Inc.20010—
+3K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—
+3K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+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
+3K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+3K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+3K093801Impella ControllerAbiomed, Inc.20101—
+3K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+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—
+4K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+4K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical20240—
+4K232132LifeSPARC SystemCardiacassist, Inc.20230—
+4K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+4K093832Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC20100—
+5K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—