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

    SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands

    K Number: K212977 · Decision Feb 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    13
    Review Days
    153

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    Basic Information

    Device Name
    SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
    K Number
    K212977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Corporation
    Date Received
    September 17, 2021
    Decision Date
    February 17, 2022
    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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