510(k) Report

Devices descending from K991864

30 later devices reach Rotaflow Centrifugal Pump System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232788Inspira ART100Inspira Technologies Oxy B.H.N., Ltd.20240—
+1K200109OXY-1 SystemAbiomed, Inc.20202Class I
+1K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC202032
+1K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation201711
+1K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+1K061072Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG200610—
+1K021694Cardiovention Powerbase Console, Model PBC-100Cardiovention, Inc.20031—
+1K020571Stockert Centrifugal Pump ConsoleStockert Instrumente GmbH20020—
+1K011838Centrifugal PumpStockert Instrumente GmbH200244
+2K250632Arctx Cool Catheter SetArctx Medical20250—
+2K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+2K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+2K223161OXY-1 SystemAbiomed, Inc.20230—
+2K222297CentriMag Pre-connected PackAbbott20220—
+2K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical, Ltd.20200—
+2K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+2K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+2K072583Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30Maquet Cardiopulmonary, AG20082—
+2K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG20081—
+2K061832Jostra HLM Tubing Sets with Safeline CoatingMaquet Cardiopulmonary, AG20060—
+2K061743Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum…Maquet Cardiopulmonary, AG20063—
+2K032213Stockert Centrifugal Pump System with Tubing ClampStockert Instrumente GmbH20030—
+2K030141Modification to Cardiovention Powerbase Console, Model PCB-100Cardiovention, Inc.20030—
+3K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—
+3K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG20092—
+3K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG20090—
+3K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG200911
+4K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+4K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+5K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I