510(k) Report

Devices descending from K082544

13 later devices reach Quart Arterial Filter with Bioline Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG2009123
+2K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+2K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+2K102532HLS Cannula Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG20111—
+2K101153Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Maquet Cardiopulmonary, AG201064
+2K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+3K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+3K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG201303
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+5K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—