BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    KAVS - CATHETER, MODELS 1107100 & 1107060

    K Number: K052844 · Decision Mar 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    1
    Review Days
    164

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    Basic Information

    Device Name
    KAVS - CATHETER, MODELS 1107100 & 1107060
    K Number
    K052844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richter & Rothe AG
    Date Received
    October 7, 2005
    Decision Date
    March 20, 2006
    Product Code
    MJN
    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
    MJN Catheter, Intravascular Occluding, Temporary

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