Cleared Traditional

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U

K212341 · Qura S.R.L · Cardiovascular
Jan 2022
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K212341 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on January 28, 2022, 184 days after receiving the submission on July 28, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K212341 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2021
Decision Date January 28, 2022
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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