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

    LEXIPLIANT DILATOR SHEATH SET

    K Number: K133631 · Decision Mar 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    103
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    LEXIPLIANT DILATOR SHEATH SET
    K Number
    K133631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectranetics Corporation
    Date Received
    November 26, 2013
    Decision Date
    March 27, 2014
    Product Code
    DRE
    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
    DRE Dilator, Vessel, For Percutaneous Catheterization

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