510(k) Report

Devices descending from K061628

29 later devices reach Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071774Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model BE-Hmod 2000…Maquet Cardiopulmonary, AG200822—
+1K072362Novalung Surgical Lung Assist (Sla) Membrane LungNovalung GmbH20075—
+2K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC202032
+2K153295TandemLung OxygenatorCardiacassist, Inc.20160—
+2K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+2K100278Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Maquet Cardiopulmonary, AG201064
+2K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG20080—
+2K082544Quart Arterial Filter with Bioline CoatingMaquet Cardiopulmonary, AG200813—
+2K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG20088221
+3K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+3K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+3K200109OXY-1 SystemAbiomed, Inc.20202Class I
+3K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+3K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+3K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+3K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+3K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG2009123
+3K083794Mecc Set with Bioline CoatingMaquet Cardiopulmonary, AG20090—
+4K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—
+4K223161OXY-1 SystemAbiomed, Inc.20230—
+4K222297CentriMag Pre-connected PackAbbott20220—
+4K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+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
+4K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+5K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+5K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG201303
+6K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—