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

    SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER

    K Number: K894942 · Decision Sep 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    432
    Review Days
    54

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    Basic Information

    Device Name
    SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
    K Number
    K894942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Boston Scientific Corp
    Date Received
    August 3, 1989
    Decision Date
    September 26, 1989
    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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