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

    PRESSURE CONNECTING TUBE

    K Number: K131770 · Decision Feb 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    497
    Applicant Total
    4
    Review Days
    254

    Basic Information

    Device Name
    PRESSURE CONNECTING TUBE
    K Number
    K131770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
    Date Received
    June 17, 2013
    Decision Date
    February 26, 2014
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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