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

    PLEURX PLEURAL CATHETER KIT, MODEL 50-7000

    K Number: K052436 · Decision Oct 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
    K Number
    K052436
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denver Biomedical, Inc.
    Date Received
    September 6, 2005
    Decision Date
    October 6, 2005
    Product Code
    DWM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWM Apparatus, Suction, Patient Care

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    Other Clearances by Denver Biomedical, Inc.

    K Number Device Name
    K051711 PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
    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