510(k) Report

Devices descending from K030449

26 later devices reach Modification to Capiox SX10 Hardshell 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
+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
+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—
+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—
+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
+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—
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+5K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L20250—
+5K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+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
+6K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—