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

    DOLPHIN INFLATION DEVICE

    K Number: K042449 · Decision Apr 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    221

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    Basic Information

    Device Name
    DOLPHIN INFLATION DEVICE
    K Number
    K042449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sedat S.A.
    Date Received
    September 9, 2004
    Decision Date
    April 18, 2005
    Product Code
    MAV
    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
    MAV Syringe, Balloon Inflation

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    Other Clearances by Sedat S.A.

    K Number Device Name
    K040498 MYSHELL