FDA.reportPublic FDA data

510(k) K220842

Device
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
Applicant
Qura S.R.L
510(k) number
K220842
Product code
KFM
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-19
Date received
2022-03-23
Regulation
870.4360
Classification name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Raffaella Tommasini
Address
Via Di Mezzo, 23 Mirandola IT 41037 41037

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KFM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.2025-08-04
K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.2025-06-24
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.L2023-10-26
K232132LifeSPARC SystemCardiacassist, Inc.2023-08-03
K200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation2021-11-18
K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L2021-11-03
K193663FloPump 57mL Centrifugal PumpInternational Biophysics Corporation2021-03-10
K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L2020-09-02
K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive SurfaceMedtronic, Inc.2020-05-21
K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.R.L2020-04-13
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.2019-08-27
K190650Revolution Centrifugal Blood PumpSorin Group Italia S.R.L.2019-08-07
K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.2019-07-09
K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation2017-12-15
K132712AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTERMedtronic, Inc.2013-11-19