K240934
- 510(k) number
- K240934
- Device name
- Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
- Applicant
- Spectrum Medical S.R.L. IT
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2026-03-12
- Date received
- 2024-04-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240934.pdf
Official FDA record: K240934
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.