510(k) Report

Devices descending from K220110

1 later device reach Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.202302