510(k) Report

Devices descending from K071774

22 later devices reach Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+1K100278Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Maquet Cardiopulmonary, AG201064
+1K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG20080—
+1K082544Quart Arterial Filter with Bioline CoatingMaquet Cardiopulmonary, AG200813—
+1K080592HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG20088221
+2K200109OXY-1 SystemAbiomed, Inc.20202Class I
+2K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+2K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+2K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+2K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+2K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+2K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG2009123
+2K083794Mecc Set with Bioline CoatingMaquet Cardiopulmonary, AG20090—
+3K223161OXY-1 SystemAbiomed, Inc.20230—
+3K222297CentriMag Pre-connected PackAbbott20220—
+3K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+3K102532HLS Cannula Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG20111—
+3K101153Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Maquet Cardiopulmonary, AG201064
+3K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+4K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+4K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG201303
+5K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—