K231982
- 510(k) number
- K231982
- Device name
- Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
- Applicant
- Qura S.R.L IT
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2024-09-12
- Date received
- 2023-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231982.pdf
Official FDA record: K231982
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.