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

    MICRO-INFUSION SYSTEM

    K Number: K062507 · Decision Nov 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    70
    Applicant Total
    23
    Review Days
    86

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    Basic Information

    Device Name
    MICRO-INFUSION SYSTEM
    K Number
    K062507
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ekos Corp.
    Date Received
    August 28, 2006
    Decision Date
    November 22, 2006
    Product Code
    QEY
    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
    QEY Mechanical Thrombolysis Catheter

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    Other Clearances by Ekos Corp.

    K Number Device Name
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    K072507 ENDOWAVE INFUSION SYSTEM
    K071933 ENDOWAVE INFUSION SYSTEM
    K063620 EKOS MICRO-INFUSION SYSTEM
    K062508 NEUROWAVE MICRO-INFUSION SYSTEM
    K060422 LYSUS INFUSION SYSTEM
    K060084 LYSUS INFUSION SYSTEM
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