510(k) K250326
K250326 is an FDA 510(k) premarket notification submitted by Spectrum Medical S.R.L. for the device "Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)". The FDA issued a decision of Substantially Equivalent on June 24, 2025. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Spectrum Medical S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2025
- Date Received
- February 5, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4360
- Review Panel
- CV
- Submission Type