BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    EpiFaith CV

    K Number: K212615 · Decision Sep 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    3
    Review Days
    399

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    Basic Information

    Device Name
    EpiFaith CV
    K Number
    K212615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flat Medical Co., Ltd.
    Date Received
    August 18, 2021
    Decision Date
    September 21, 2022
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Flat Medical Co., Ltd.

    K Number Device Name
    K192421 EpiFaith Syringe
    K182268 EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)