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

    CORONARY GUIDING CATHETER

    K Number: K830829 · Decision Apr 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    103
    Review Days
    45

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    Basic Information

    Device Name
    CORONARY GUIDING CATHETER
    K Number
    K830829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Advanced Cardiovascular Systems, Inc.
    Date Received
    March 14, 1983
    Decision Date
    April 28, 1983
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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