510(k) Report

Devices descending from K960074

44 later devices reach Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062381Capiox RX Oxygenator with or Without ReservoirTerumo Cardiovascular Systems Corp.200692
+1K051997Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp.2005251
+1K991452Cobe Optimin Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc.1999192
+2K130333Capix RX Hollow Fiber Oxygenator with/Without Hardshell ReservoirTerumo Cardiovascular Systems Corp.20137—
+2K090689Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…Maquet Cardiopulmonary, AG200995
+2K090450Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTGish Biomedical, Inc.20092—
+2K082321Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp.20090—
+2K071494Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterTerumo Corp.2007712
+2K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDideco S.R.L.2005171
+2K013480Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc.200102
+3K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.L20240—
+3K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell ReservoirTerumo Cardiovascular Systems Corporation20150—
+3K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L.20155—
+3K140774Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirTerumo Cardiovascular Systems Corporation20145—
+3K140177Medos Hilite OxygenatorMedos Medizintechnik AG20140—
+3K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+3K130520Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirAshitaka Factory of Terumo Corp.20136—
+3K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L.20128—
+3K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+3K093522Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…Maquet Cardiopulmonary, AG200983
+3K050890Ecc.O SystemDideco S.R.L.20051—
+4K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L20260—
+4K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…Eurosets S.R.L20250—
+4K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+4K211495Eos PMPSorin Group Italia S.R.L.20210—
+4K202206AMG PMP PediatricEurosets S.R.L20211—
+4K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L.20185—
+4K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…Terumo Cardiovascular Systems Corporation201522
+4K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell…Terumo Cardiovascular Systems Corporation20151—
+4K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+4K130209Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow…Sorin Group Italia S.R.L.201301
+4K121909Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy…Sorin Group Italia S.R.L.20120—
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG20080—
+5K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.20260—
+5K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—
+5K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L20250—
+5K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…Qura S.R.L20220—
+5K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M…Sorin Group Italia S.R.L.20200—
+5K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow…Sorin Group Italia S.R.L.20200—
+5K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation201805
+5K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…Terumo Cardiovascular Systems Corporation20180—
+5K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I