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510(k) Data Aggregation

    K Number
    K250326
    Device Name
    Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
    Manufacturer
    Spectrum Medical S.r.l.
    Date Cleared
    2025-06-24

    (139 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. Device is intended for adult patients.
    Device Description
    The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours. The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.
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    K Number
    K233091
    Device Name
    Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
    Manufacturer
    Qura S.r.l.
    Date Cleared
    2023-10-26

    (30 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either: (i) Full of partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. Devices are intended for adult patients.
    Device Description
    The Quantum Perfusion Centrifugal Blood Pump with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors. The device is non-toxic, non pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
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    K Number
    K232132
    Device Name
    LifeSPARC System
    Manufacturer
    CardiacAssist, Inc.
    Date Cleared
    2023-08-03

    (16 days)

    Product Code
    KFM, DWA
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
    Device Description
    The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient. The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.
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    K Number
    K220842
    Device Name
    Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
    Manufacturer
    Qura S.r.l.
    Date Cleared
    2023-05-19

    (422 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Perfusion Centrifugal Blood Pump CP20, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age) The Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors, indicated for use exclusively with Quantum Centrifugal Drive of Spectrum Medical, is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either: Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on (i) the heart or great vessels; or Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava. Device is intended for adolescent patients (i.e., patients greater than 12 through 21 years of age)
    Device Description
    Quantum Perfusion Centrifugal Blood Pump CP20 and Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors are standalone single use device intended to pump blood into the extracorporeal circulation circuit and to monitor pressure for periods lasting less than 6 hours. Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors is equipped with two sensors integrated in the blood inlet and outlet connectors. Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
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    K Number
    K200091
    Device Name
    Capiox iCP Centrifugal Pump
    Manufacturer
    Terumo Cardiovascular Systems Corporation
    Date Cleared
    2021-11-18

    (672 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours. The pump is intended for use with Terumo® Advanced Perfusion System 1 / Sams™ Centrifugal Pump Systems or may be used with the Stockert / Sorin Centrifugal Pump Consoles.
    Device Description
    The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump.
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    K Number
    K201320
    Device Name
    Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
    Manufacturer
    Qura S.r.l.
    Date Cleared
    2021-11-03

    (534 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive of Spectrum Medical is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway (ii) necessary for open surgical procedures on the aorta or vena cava.
    Device Description
    The Quantum Perfusion Centrifygal Blood Pump CP22 with Integrated Sensors is a standalone single use device intended to pump blood into the extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours. The device is equipped with two sensors integrated in the blood inlet and outlet connectors. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
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    K Number
    K193663
    Device Name
    FloPump 57mL Centrifugal Pump
    Manufacturer
    International Biophysics Corporation
    Date Cleared
    2021-03-10

    (435 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
    Device Description
    The FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.
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    K Number
    K202169
    Device Name
    Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
    Manufacturer
    Qura S.r.l
    Date Cleared
    2020-09-02

    (30 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum PureFlow Centrifugal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical (i) procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
    Device Description
    The Quantum PureFlow Centrifugal Blood Pump CP22/Quantum PureFlow Centrifugal Blood Pump CP37 is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circulation circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
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    K Number
    K201068
    Device Name
    Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2020-05-21

    (29 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Affinity CP centrifugal blood pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The Affinity CP centrifugal blood pump is driven by the external drive motor or the emergency handcrank. The Affinity CP centrifugal blood pump is intended for use with pump speed controllers approved by Medtronic or may be used with the Stöckert and Sorin centrifygal pump systems or the Sams and Terumo centrifygal systems by attaching the Affinity CP adapter.
    Device Description
    Not Found
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    K Number
    K192850
    Device Name
    Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
    Manufacturer
    Qura S.r.l.
    Date Cleared
    2020-04-13

    (193 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Product Code :

    KFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum PureFlow Centrifugal Blood Pump indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
    Device Description
    The Quantum PureFlow Centrifygal Blood Pump is a standalone, single use device intended to be used in medical procedures requiring extracorporeal circuits. The pump is designed to move blood by centrifugal force and allow blood flow through the cardiopulmonary bypass or extracorporeal circulation circuits for periods lasting up to 6 hours. The pump is designed to allow the passage of blood through an impeller rotating around its axis. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single blister. Blood contact surfaces of the device are coated with a stable biocompatible surface to reduce platelet activation and adhesion while preserving platelet function.
    Ask a Question

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