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510(k) K250326

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) by Spectrum Medical S.R.L. — Product Code KFM

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

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