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FDA 510(k)

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor

K-Number: K201320 · 2021-11-03

ApplicantQura S.R.L
Decision Date2021-11-03
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor is a medical device manufactured by Qura S.R.L. It received FDA 510(k) clearance on 2021-11-03 under approval number K201320. 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 PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor?

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor is a medical device that received FDA 510(k) clearance on 2021-11-03. It is manufactured by Qura S.R.L. The 510(k) number is K201320.

When was Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor approved by the FDA?

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor received FDA 510(k) clearance on 2021-11-03, under approval number K201320.

What company makes Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor?

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor is manufactured by Qura S.R.L.

What is the FDA product code for Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor?

The FDA product code for Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor is KFM.

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Other Devices by Qura S.R.L

K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F K203057Quantum Perfusion Arterial Cannula Graft K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS

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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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