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510(k) Data Aggregation

    K Number
    K221400
    Device Name
    hygh-tec drainage
    Manufacturer
    Creative Balloons GmbH
    Date Cleared
    2023-02-09

    (269 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Creative Balloons GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liguid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.
    Device Description
    The hygh-tec drainage is sold as a kit to include a main catheter component, collection bag, inflation syringe, and closure strap. The catheter component consists of a retaining and sealing balloon element, a trans-anal segment, drainage shaft, an elastically deformable tip, a colored positioning ring, a stool irrigation tube, an irrigation line, and an air filling line.
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