510(k) K213540

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set by Qura S.R.L — Product Code DWF

K213540 is an FDA 510(k) premarket notification submitted by Qura S.R.L for the device "Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set". The FDA issued a decision of Substantially Equivalent on May 20, 2022. 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.