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

    MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)

    K Number: K022042 · Decision Sep 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    71

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    Basic Information

    Device Name
    MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
    K Number
    K022042
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardeon Corp.
    Date Received
    June 24, 2002
    Decision Date
    September 3, 2002
    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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    Other Clearances by Cardeon Corp.

    K Number Device Name
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    K013593 CARDEON AEGIS CATHETER
    K001371 CARDEON ASCENDING BALLOON CANNULA (ABC)