Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F

About This 510(k) Submission

K203067 is an FDA 510(k) clearance for the Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on November 8, 2021, 395 days after receiving the submission on October 9, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.