510(k) Report

Devices descending from K963518

20 later devices reach Cobe Optima XP Hollow Fiber Membrane Oxygenator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991452Cobe Optimin Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc.1999192
+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
+3K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L.20155—
+3K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L.20128—
+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—
+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—
+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—
+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—