510(k) Report

Devices descending from K083021

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092895Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L.200931
+2K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L20222—
+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