Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
FDA 510(k) clearance K220842 · decided 2023-05-19
Clearance details
- K-number
- K220842
- Device name
- Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
- Applicant
- Qura S.R.L
- Decision
- Substantially Equivalent
- Date received
- 2022-03-23
- Decision date
- 2023-05-19
- Days to decision
- 422 days
- Clearance type
- Traditional
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- 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.