510(k) K241248

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) by Spectrum Medical S.R.L. — Product Code DWF

K241248 is an FDA 510(k) premarket notification submitted by Spectrum Medical S.R.L. for the device "Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Spectrum Medical S.R.L. has at least 10 other 510(k) clearances on record.