BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PVC Hydrophilic Urethral Catheter

    K Number: K212567 · Decision Dec 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    478

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    Basic Information

    Device Name
    PVC Hydrophilic Urethral Catheter
    K Number
    K212567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chengdu Daxan Innovative Medical Tech. Co., Ltd.
    Date Received
    August 16, 2021
    Decision Date
    December 7, 2022
    Product Code
    EZD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EZD Catheter, Straight

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