BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇳 China

    Type I, Type II, Type III, Type IV

    K Number: K172331 · Decision Mar 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    7
    Review Days
    212

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    Basic Information

    Device Name
    Type I, Type II, Type III, Type IV
    K Number
    K172331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Lepu Medical Technology (Beijing) Co., Ltd.
    Date Received
    August 2, 2017
    Decision Date
    March 2, 2018
    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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