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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    International Biophysics Corporation

    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
    K170029
    Device Name
    FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Date Cleared
    2017-12-15

    (345 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL BIOPHYSICS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloPump 32mL 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 32mL 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 Maquet RotaFlow console and rotates the internal impeller using a magnetic driver. The FloPump 32mL 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 32mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 32mL does not have any other patient contact.
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    K Number
    K122480
    Device Name
    INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORPORATION
    Date Cleared
    2013-03-27

    (225 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL BIOPHYSICS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The International Biophysics Corporation AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment.
    Device Description
    The International Biophysics Corporation HFCWO Vibratory Vest is comprised of a vest of synthetic polymer fabric with installed oscillating vibratory motors organized into six zones. It has three buckles and straps on the front and one over each shoulder that are used to provide the wearer with a snug and evenly-distributed fit. Additionally, there is an included charger for the batteries and a remote that is wired into the vest to adjust the intensity of the oscillation on the patient as necessary and as prescribed by a physician.
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