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

    CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER

    K Number: K030966 · Decision Sep 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    7
    Applicant Total
    432
    Review Days
    180

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    Basic Information

    Device Name
    CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
    K Number
    K030966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    March 27, 2003
    Decision Date
    September 23, 2003
    Product Code
    NAJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NAJ Agents, Embolic, For Treatment Of Uterine Fibroids

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