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

    TENDERFLOW PERIATRIC ARTERIAL CANNULA

    K Number: K063618 · Decision Mar 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    43
    Review Days
    98

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    Basic Information

    Device Name
    TENDERFLOW PERIATRIC ARTERIAL CANNULA
    K Number
    K063618
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corp.
    Date Received
    December 5, 2006
    Decision Date
    March 13, 2007
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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