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

    3-DAY BIOINDICATOR RELEASE PROCESS FOR

    K Number: K833830 · Decision Apr 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    174
    Review Days
    157

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    Basic Information

    Device Name
    3-DAY BIOINDICATOR RELEASE PROCESS FOR
    K Number
    K833830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Shiley, Inc.
    Date Received
    November 7, 1983
    Decision Date
    April 12, 1984
    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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