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510(k) Data Aggregation

    K Number
    K241424
    Device Name
    InnoCare Specialty Foley Catheter
    Manufacturer
    InnoCare Urologics, LLC
    Date Cleared
    2024-09-18

    (121 days)

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

    InnoCare Urologics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InnoCare Specialty Foley Catheter is intended for urethral catheterization for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.
    Device Description
    The InnoCare Specialty Foley Catheter is a 16 French, two-way silicone Foley catheter for urethral catheterization to drain urine from the bladder. The catheter is retained in the bladder by use of a retention balloon attached to the distal end of the catheter. The device is offered in a straight tip configuration and a Coude tip configuration. The inflation lumen of the catheter contains a secondary balloon deflation mechanism. This mechanism is designed to provide a fluid escape pathway to allow for balloon deflation in the event of a forced withdrawal or catheter pullout. The device is provided sterile and for single use.
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