510(k) Report

Devices descending from K932252

50 later devices reach Affinity Hollow Fiber Oxygenator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143073Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT…Medtronic, Inc.20152—
+1K992559Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley199945—
+1K992910Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance…Medtronic Vascular19990—
+2K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium BiosurfaceMedtronic, Inc.20160—
+2K162016Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, Inc.20160—
+2K061628Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030Maquet Cardiopulmonary, AG200629—
+2K061072Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG200610—
+2K030264Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG200343—
+2K013038Safe Maxi Hollow Fiber Oxygenator, Model 016010Polystan A/S20020—
+3K082117Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Maquet Cardiopulmonary, AG2009215
+3K072583Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30Maquet Cardiopulmonary, AG20082—
+3K071774Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000…Maquet Cardiopulmonary, AG200822—
+3K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG20081—
+3K072362Novalung Surgical Lung Assist (Sla) Membrane LungNovalung GmbH20075—
+3K061832Jostra HLM Tubing Sets with Safeline CoatingMaquet Cardiopulmonary, AG20060—
+3K061743Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum…Maquet Cardiopulmonary, AG20063—
+4K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC202032
+4K153295TandemLung OxygenatorCardiacassist, Inc.20160—
+4K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+4K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K102532HLS Cannula Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG20111—
+4K101153Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Maquet Cardiopulmonary, AG201064
+4K100278Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Maquet Cardiopulmonary, AG201064
+4K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG20092—
+4K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG20090—
+4K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG200911
+4K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+4K090518Quart Arterial Filter with Softline CoatingMaquet Cardiopulmonary, AG20090—
+4K090515Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa)Maquet Cardiopulmonary, AG200901
+4K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG2009123
+4K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG20080—
+4K082544Quart Arterial Filter with Bioline CoatingMaquet Cardiopulmonary, AG200813—
+4K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG20088221
+5K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+5K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+5K200109OXY-1 SystemAbiomed, Inc.20202Class I
+5K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+5K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+5K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+5K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG201303
+5K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+5K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+5K083794Mecc Set with Bioline CoatingMaquet Cardiopulmonary, AG20090—
+6K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—
+6K223161OXY-1 SystemAbiomed, Inc.20230—
+6K222297CentriMag Pre-connected PackAbbott20220—
+6K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+6K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I
+7K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—