Cleared Traditional

Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

K231982 · Qura S.R.L · Cardiovascular
Sep 2024
Decision
435d
Days
Class 2
Risk

About This 510(k) Submission

K231982 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-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 September 12, 2024, 435 days after receiving the submission on July 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K231982 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2023
Decision Date September 12, 2024
Days to Decision 435 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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