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

    RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX

    K Number: K100892 · Decision Apr 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    432
    Review Days
    12

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    Basic Information

    Device Name
    RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
    K Number
    K100892
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    March 31, 2010
    Decision Date
    April 12, 2010
    Product Code
    KRA
    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
    KRA Catheter, Continuous Flush

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