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

    DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

    K Number: K962814 · Decision Apr 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    4
    Review Days
    269

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    Basic Information

    Device Name
    DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
    K Number
    K962814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5955
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denver Biomaterials, Inc.
    Date Received
    July 19, 1996
    Decision Date
    April 14, 1997
    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 Biomaterials, Inc.

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    K971753 DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
    K960456 DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY