Cleared Traditional

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, 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

K231773 · Qura S.R.L · Cardiovascular
Nov 2023
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K231773 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, 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, 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 November 8, 2023, 145 days after receiving the submission on June 16, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K231773 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2023
Decision Date November 08, 2023
Days to Decision 145 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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