510(k) K252541

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W by Spectrum Medical S.R.L. — Product Code DTR

K252541 is an FDA 510(k) premarket notification submitted by Spectrum Medical S.R.L. for the device "Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Spectrum Medical S.R.L. has at least 10 other 510(k) clearances on record.