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510(k) Data Aggregation

    K Number
    K030538
    Device Name
    AMERICAN CATHETER, MODEL W3
    Manufacturer
    CATHETER LLC.
    Date Cleared
    2003-03-10

    (18 days)

    Product Code
    EZDPRE
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHETER LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Used for female intermittent self-catheterization of the bladder. Curved design permits easier insertion and makes the catheter easier for patients to manipulate.
    Device Description
    Not Found
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