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

    INFLATION DEVICE

    K Number: K830609 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    4
    Review Days
    27

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    Basic Information

    Device Name
    INFLATION DEVICE
    K Number
    K830609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Interventional Medical, Inc.
    Date Received
    February 25, 1983
    Decision Date
    March 24, 1983
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Interventional Medical, Inc.

    K Number Device Name
    K880831 LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
    K841071 PRESSURE MANOMETER
    K822243 GUIDING CATHETER