Cleared Special

Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS

K221353 · Qura S.R.L · Cardiovascular

Aug 2022

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K221353 is an FDA 510(k) clearance for the Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS, 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 August 18, 2022, 100 days after receiving the submission on May 10, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K221353 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2022
Decision Date	August 18, 2022
Days to Decision	100 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210