Cleared Traditional

Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2

K203424 · Qura S.R.L · Cardiovascular
Dec 2021
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K203424 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2, 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 December 17, 2021, 392 days after receiving the submission on November 20, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K203424 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2020
Decision Date December 17, 2021
Days to Decision 392 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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