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FDA 510(k)

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)

K-Number: K250326 · 2025-06-24

ApplicantSpectrum Medical S.R.L.
Decision Date2025-06-24
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a medical device manufactured by Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2025-06-24 under approval number K250326. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)?

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a medical device that received FDA 510(k) clearance on 2025-06-24. It is manufactured by Spectrum Medical S.R.L.. The 510(k) number is K250326.

When was Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) approved by the FDA?

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) received FDA 510(k) clearance on 2025-06-24, under approval number K250326.

What company makes Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)?

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is manufactured by Spectrum Medical S.R.L..

What is the FDA product code for Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)?

The FDA product code for Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is KFM.

Related Clinical Trials

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Other Devices by Spectrum Medical S.R.L.

K241206Quantum Perfusion Hybrid System K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

Related Devices (Code: KFM)

K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation K191077Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive MotorMedtronic, Inc. K190650Revolution Centrifugal Blood PumpSorin Group Italia S.R.L. K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive SurfaceMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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