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510(k) Data Aggregation

    K Number
    K172422
    Device Name
    Kohli Urinary Drainage Catheter
    Manufacturer
    Nellie Medical, LLC
    Date Cleared
    2018-02-09

    (183 days)

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

    Nellie Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 2-Way Kohli urinary drainage catheter is intended for urological bladder drainage only with a maximum patient indwelling time of <30 days.
    Device Description
    The Kohli Urinary Drainage Catheter is intended for drainage of the urinary bladder. The Kohli Urinary Drainage Catheter provides a single use access catheter with two ports: One for bladder drainage, and one for balloon inflation. The catheter encompasses only one balloon size (5cc) and length and it does not include any hydrophilic or antimicrobial coating
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