510(k) Report

Devices descending from K020997

5 later devices reach Apex PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083021Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L.200842
+2K092895Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L.200931
+3K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L20222—
+4K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L202212
+5K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.202302