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

    MODIFICATION OF THE PERCUTAN-BALLOON

    K Number: K813355 · Decision Jul 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    217

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    Basic Information

    Device Name
    MODIFICATION OF THE PERCUTAN-BALLOON
    K Number
    K813355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Smec, Inc.
    Date Received
    November 27, 1981
    Decision Date
    July 2, 1982
    Product Code
    DSP
    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
    DSP System, Balloon, Intra-Aortic And Control

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    Other Clearances by Smec, Inc.

    K Number Device Name
    K840367 PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
    K840037 MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC
    K832753 PERCUTANEOUS BALLOON
    K823739 INTRA-AORTIC BALLOON SYSTEM
    K823177 SMEC BALLOON SYSTEM
    K790755 SMEC BALLOON CANNULA