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510(k) Data Aggregation

    K Number
    K210358
    Device Name
    Neurescue device
    Manufacturer
    Neurescue Aps
    Date Cleared
    2021-05-21

    (102 days)

    Product Code
    MJN, DQO, DQY
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurescue Aps

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neurescue device is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.
    Device Description
    The NEURESCUE device is a large vessel occlusion catheter comprised of two main components: The NEURESCUE Catheter and the NEURESCUE Assistant. The Catheter is an occlusion balloon catheter and the Assistant is a hub for interfacing with the operation of the Catheter. During normal use the device can be operated automatically. Alternatively, the device can be operated manually. For manual use the interface consists of two Luer lock ports for: - Manual inflation and deflation of the balloon with saline - - -Flushing of the arterial FLUSH port with saline Inflation and deflation of the balloon can be accomplished by an automatic filling and deflation function (automatic operation with a peristaltic pump) or manually. Whether the filling is performed manually or automatically, the user is informed of the pressure at the tip of the Catheter. The device has a built-in alarms system.
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