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

    PRESSURE TRIGGER MOD OF SMEC INTRA-AORT

    K Number: K840367 · Decision Dec 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    7
    Review Days
    684

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    Basic Information

    Device Name
    PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
    K Number
    K840367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Smec, Inc.
    Date Received
    January 27, 1984
    Decision Date
    December 11, 1985
    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
    K840037 MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC
    K832753 PERCUTANEOUS BALLOON
    K823739 INTRA-AORTIC BALLOON SYSTEM
    K823177 SMEC BALLOON SYSTEM
    K813355 MODIFICATION OF THE PERCUTAN-BALLOON
    K790755 SMEC BALLOON CANNULA