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

    BLADE SEPTOSTOMY CATHETER

    K Number: K801031 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    19
    Applicant Total
    190
    Review Days
    88

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    Basic Information

    Device Name
    BLADE SEPTOSTOMY CATHETER
    K Number
    K801031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5175
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cook, Inc.
    Date Received
    May 1, 1980
    Decision Date
    July 28, 1980
    Product Code
    DXF
    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
    DXF Catheter, Septostomy

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