510(k) Report

Devices descending from K842908

27 later devices reach Variable Prime Cobe Membrane Lung through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022115Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirTerumo Corp.200226—
+2K130493Capiox RX05 Hollow Fiber Oxygenator/ReservoirTerumo Corporation20130—
+2K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+2K102464Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with…Maquet Cardiopulmonary, AG20116Class I
+2K090449Medos Hilite Infant Oxygenator, Model 1000, 800 LTGish Biomedical, Inc.20091—
+2K091062Medos Hilite Infant Reservoir, Model MVC 0730Gish Biomedical, Inc.20090—
+2K071572Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial FilterTerumo Corp.20071—
+2K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp.200692
+2K033800Capiox Cardiotomy ReservoirTerumo Cardiovascular Systems Corporation20040—
+3K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I
+3K140181Medos Hilite Infant OxygenatorMedos Medizintechnik AG20140—
+3K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+3K130333Capix RX Hollow Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp.20137—
+3K130280Capiox FX Hollow Fiber Oxygenator W/ ReservoirTerumo Corporation20130—
+3K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+3K082321Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp.20090—
+4K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell ReservoirTerumo Cardiovascular Systems Corporation20150—
+4K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+4K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation20145—
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+5K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+5K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…Terumo Cardiovascular Systems Corporation201522
+5K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell…Terumo Cardiovascular Systems Corporation20151—
+6K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—
+6K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L20250—
+6K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation201805
+6K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation20180—