Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
FDA 510(k) clearance K231982 · decided 2024-09-12
Clearance details
- K-number
- K231982
- Device name
- Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
- Applicant
- Qura S.R.L
- Decision
- Substantially Equivalent
- Date received
- 2023-07-05
- Decision date
- 2024-09-12
- Days to decision
- 435 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.