BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS

    K Number: K051711 · Decision Nov 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    14
    Applicant Total
    5
    Review Days
    141

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    Basic Information

    Device Name
    PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
    K Number
    K051711
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denver Biomedical, Inc.
    Date Received
    June 27, 2005
    Decision Date
    November 15, 2005
    Product Code
    PNG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

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    Other Clearances by Denver Biomedical, Inc.

    K Number Device Name
    K052436 PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
    K012235 DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
    K011862 DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
    K011831 MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS