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510(k) Data Aggregation

    K Number
    K221694
    Device Name
    External Drainage System
    Manufacturer
    JMED(Shenzhen) Technology Limited
    Date Cleared
    2023-02-09

    (244 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    JMED(Shenzhen) Technology Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).
    Device Description
    The External Drainage System includes a tubing, drainage bag, drip chamber and scale plate. It is provided sterile and can be connected to a drainage catheter, which is connected to a patient line, via a luer connection and ultimately to a drainage bag. The drainage catheter is not included in the subject device. The External Drainage System provides a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space. During the draining, the cerebrospinal fluid will be collected in a drainage bag.
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