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— 510(k) K203424

Substantially Equivalent

Qura S.R.L

FDA 510(k) clearance K203424 for 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, Substantially Equivalent on 2021-12-17. Applicant: Qura S.R.L.

Clearance details

Applicant: Qura S.R.L
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2020-11-20
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.