FDA 510(k)

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)

Numéro K : K251762 · 2025-08-04

Date de décision2025-08-04

Code produitKFM

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2025-08-04 under 510(k) number K251762. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is a medical device that received FDA 510(k) clearance on 2025-08-04. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K251762.

When did Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) receive FDA 510(k) clearance?

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) received FDA 510(k) clearance on 2025-08-04, under 510(k) number K251762.

Who is the listed applicant for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

The FDA 510(k) record lists Spectrum Medical S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

The FDA product code for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is KFM.

Essais cliniques associés

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Autres dossiers indiquant Spectrum Medical S.R.L. en tant que demandeur

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);K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)K241206Quantum Perfusion Hybrid System K241248Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

Dispositifs connexes (Code : KFM)

K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)Qura S.R.L K232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.L K200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L

Source officielle

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