K231773
- 510(k) number
- K231773
- Device name
- 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
- Applicant
- Qura S.R.L IT
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2023-11-08
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231773.pdf
Official FDA record: K231773
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.