510(k) Report

Devices descending from K082117

21 later devices reach Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+1K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+1K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+1K102532HLS Cannula Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG20111—
+1K101153Quadrox-ID Adult Diffusion Membrane Oxygenator with Softline Coating, Model: BE-Hmod…Maquet Cardiopulmonary, AG201064
+1K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG20090—
+1K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG20092—
+1K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG200911
+1K090533HLM Tubing Set with Softline CoatingMaquet Cardiopulmonary, AG20093—
+1K090518Quart Arterial Filter with Softline CoatingMaquet Cardiopulmonary, AG20090—
+1K090515Rotaflow Centrifugal Pump with Softline Coating, Model BO-RF-32 (Usa)Maquet Cardiopulmonary, AG200901
+1K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG2009123
+2K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+2K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+2K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+2K131666Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingMaquet Cardiopulmonary, AG201303
+2K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+2K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+3K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+3K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I
+4K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—