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

    Medcomp Vessel Dilator

    K Number: K162389 · Decision Jun 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    103
    Applicant Total
    7
    Review Days
    279

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    Basic Information

    Device Name
    Medcomp Vessel Dilator
    K Number
    K162389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medcomp ( Medical Components)
    Date Received
    August 26, 2016
    Decision Date
    June 1, 2017
    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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