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

    MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)

    K Number: K853136 · Decision Dec 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    130

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    Basic Information

    Device Name
    MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
    K Number
    K853136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    E.A. Fischione Instrument Mfg.
    Date Received
    July 26, 1985
    Decision Date
    December 3, 1985
    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 E.A. Fischione Instrument Mfg.

    K Number Device Name
    K841493 MODEL 1000 APC-ANGIOPLASTY PRESSURE