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

    AXIOM PERFUSSION CANNULA

    K Number: K832475 · Decision Oct 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    28
    Review Days
    85

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    Basic Information

    Device Name
    AXIOM PERFUSSION CANNULA
    K Number
    K832475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Axiom Medical, Inc.
    Date Received
    July 26, 1983
    Decision Date
    October 19, 1983
    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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    K922760 ATRAUM WOUND DRESSING--MODIFICATION
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    K904218 SUCTION SYSTEM
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