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

    CARDIOPULMONARY BYPASS TUBING

    K Number: K801401 · Decision Jun 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    30
    Review Days
    17

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    Basic Information

    Device Name
    CARDIOPULMONARY BYPASS TUBING
    K Number
    K801401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Texas Medical Products, Inc.
    Date Received
    June 13, 1980
    Decision Date
    June 30, 1980
    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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