Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
FDA 510(k) clearance K250326 · decided 2025-06-24
Clearance details
- K-number
- K250326
- Device name
- Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- Applicant
- Spectrum Medical S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-05
- Decision date
- 2025-06-24
- Days to decision
- 139 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.