510(k) Report

Devices descending from K033323

28 later devices reach D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121536Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell ReservoirSorin Group Italia S.R.L.201210—
+1K121229Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/CardiotomySorin Group Italia S.R.L.201212—
+1K043323D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDideco S.R.L.2005171
+2K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…Sorin Group Italia S.R.L.20185—
+2K150489EOS PMP, EOS PMP IntegratedSorin Group Italia S.R.L.20155—
+2K130433Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…Sorin Group Italia S.R.L.201321
+2K122844Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L.20123—
+2K122254Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSorin Group Italia S.R.L.20126—
+2K120185Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Sorin Group Italia S.R.L.20128—
+2K050890Ecc.O SystemDideco S.R.L.20051—
+3K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L20260—
+3K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.20250—
+3K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…Eurosets S.R.L20250—
+3K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.20240—
+3K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…Qura S.R.L20220—
+3K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…Qura S.R.L20211—
+3K211495Eos PMPSorin Group Italia S.R.L.20210—
+3K202206AMG PMP PediatricEurosets S.R.L20211—
+3K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackChalice Medical, Ltd.20201—
+3K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M…Sorin Group Italia S.R.L.20200—
+3K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow…Sorin Group Italia S.R.L.20200—
+3K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)Chalice Medical, Ltd.20200—
+3K130209Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow…Sorin Group Italia S.R.L.201301
+3K121909Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy…Sorin Group Italia S.R.L.20120—
+3K082412Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model BE-VBT…Mapquet Cardiopulmonary AG20080—
+4K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.20260—
+4K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…Spectrum Medical S.R.L.20260—
+4K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)Chalice Medical, Ltd.20230—