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

    7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH

    K Number: K802481 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    16
    Review Days
    24

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    Basic Information

    Device Name
    7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
    K Number
    K802481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Waters Assoc., Inc.
    Date Received
    October 7, 1980
    Decision Date
    October 31, 1980
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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