510(k) Report

Devices descending from K212688

2 later devices reach Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L202212
+2K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.202302