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

    DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

    K Number: K012235 · Decision Oct 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    79

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    Basic Information

    Device Name
    DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
    K Number
    K012235
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5955
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denver Biomedical, Inc.
    Date Received
    July 17, 2001
    Decision Date
    October 4, 2001
    Product Code
    KPM
    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
    KPM Shunt, Peritoneal

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    Other Clearances by Denver Biomedical, Inc.

    K Number Device Name
    K051711 PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
    K052436 PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
    K011862 DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
    K011831 MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS