510(k) Report

Devices descending from K014080

6 later devices reach Apex Adult Hollowe Fiber Oxygenator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092895Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L.200931
+1K020997Apex PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDideco S.P.A.200252
+2K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L20222—
+2K083021Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L.200842
+3K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L202212
+4K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.202302