510(k) Report

Devices descending from K991737

14 later devices reach Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061031D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L.200613—
+2K072091D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…Sorin Group Italia S.R.L.200712—
+3K231652D100 Kids; D101 KidsSorin Group Italia S.R.L.20230—
+3K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…Qura S.R.L20230—
+3K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG201112
+3K103191Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with…Maquet Cardiopulmonary, AG201164
+3K100278Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models BE-Hmod…Maquet Cardiopulmonary, AG201064
+4K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG20140Class I
+4K132829Quadrox-I, Quadrox-ID, Quadrox-IR OxygenatorsMaquet Cardiopulmonary, AG201341
+4K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG2011012
+5K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsMaquet Cardiopulmonary, AG201522
+5K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+6K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+7K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—