510(k) K203067

Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F by Qura S.R.L — Product Code DWF

K203067 is an FDA 510(k) premarket notification submitted by Qura S.R.L for the device "Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F". The FDA issued a decision of Substantially Equivalent on November 8, 2021. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Qura S.R.L has at least 10 other 510(k) clearances on record.