510(k) K223879

Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) by Quara S.R.L. — Product Code DTR

K223879 is an FDA 510(k) premarket notification submitted by Quara S.R.L. for the device "Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)". The FDA issued a decision of Substantially Equivalent on April 13, 2023. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240.