510(k) K212341— 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

Substantially Equivalent

Qura S.R.L

Clearance details

Applicant: Qura S.R.L
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2021-07-28
Decision date: 2022-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

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.