510(k) Report

Devices descending from K896978

49 later devices reach Closed Chest Support Circuit W/Bio-Active Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973011BPX80 Bio-Pump (BPX80)Medtronic Bio-Medicus, Inc.199848—
+2K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC202032
+2K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc.20115—
+2K111658Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive SurfaceMedtronic, Inc.20117—
+2K100631Affiity CP Centrifugal Blood PumpMedtronic, Inc.20109—
+2K080774Capiox SP Pump (with or Without X-Coating)Terumo Cardiovascular Systems Corp.20080—
+2K050109Trillium Biopump Plus, Model BPX80TMedtronic Perfusion Systems20056—
+2K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC200321Class I
+2K020529Large Centrifugal Blood Pump, Model CP-2A-Med Systems, Inc.20020—
+2K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc.200013—
+2K992592A-Miniature Centrifugal Blood Pump System, Model CPB 2000A-Med Systems, Inc.20002—
+3K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+3K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+3K191557CentriMag Acute Circulatory Support SystemThoratec Corporation (Now Part of Abbott)20192—
+3K132712Affinity CP Centrifugal Blood Pump with or Without Coating, Affinity CP AdapterMedtronic, Inc.20130—
+3K131179Centrimag Primary Console (2ND Generation); Mag MonitorThoratec Corp201301
+3K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc.201242
+3K110493Tandemheart PumpCardiacassist, Inc.201128
+3K111657Affinity CP Centrifugal Blood Pump with Balance BiosurfaceMedtronic, Inc.20111—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K102129Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorLevitronix, LLC20104—
+3K090051Levitronix Pedimag Blood Pump, Model 201-90052Levitronix, LLC200921
+3K073631Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation20080—
+3K081221Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleLevitronix, LLC200810—
+3K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+3K061369Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc.20064—
+3K053630Levitronix Centrimag Primary ConsoleLevitronix, LLC200611—
+3K051209Levitronix Centrimag Back-UP ConsoleLevitronix, LLC200521
+3K013393Heparin Coated Miniature Centrifugal Bypass Pump System;Model #CP-1HA-Med Systems, Inc.20010—
+4K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—
+4K250937Venous Return CannulaeLivaNova USA, Inc.20260—
+4K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion…Qura S.R.L20231—
+4K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…Abbott (Formerly Thoratec Corporation)20201—
+4K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.20191Class I
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K140165MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage…Medtronic, Inc.20142—
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+4K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+4K093801Impella ControllerAbiomed, Inc.20101—
+4K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+4K090004Levitronix, Thoratec Centrimag Back-UP ConsolesLevitronix, LLC200911
+4K083340Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleLevitronix, LLC200891
+5K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.20250—
+5K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaMedtronic, Inc.20251—
+5K234118CentriMag™ Acute Circulatory Support SystemAbbott Medical20240—
+5K232132LifeSPARC SystemCardiacassist, Inc.20230—
+5K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+5K093832Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC20100—
+6K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L.20260—