510(k) K241206

Quantum Perfusion Hybrid System by Spectrum Medical S.R.L. — Product Code DTN

K241206 is an FDA 510(k) premarket notification submitted by Spectrum Medical S.R.L. for the device "Quantum Perfusion Hybrid System". The FDA issued a decision of Substantially Equivalent on July 18, 2024. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Spectrum Medical S.R.L. has at least 10 other 510(k) clearances on record.