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

    GDS-DC12

    K Number: K100135 · Decision Apr 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    271
    Registration Numbers
    272
    Same Product Code
    880
    Applicant Total
    2
    Review Days
    87

    Basic Information

    Device Name
    GDS-DC12
    K Number
    K100135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GUIDED DELIVERY SYSTEMS
    Date Received
    January 19, 2010
    Decision Date
    April 16, 2010
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQY Catheter, Percutaneous

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