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

    4F STERILE BALLOON-LESS, CATHETER 913-28

    K Number: K791026 · Decision Jun 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    16
    Review Days
    18

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    Basic Information

    Device Name
    4F STERILE BALLOON-LESS, CATHETER 913-28
    K Number
    K791026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Waters Assoc., Inc.
    Date Received
    June 4, 1979
    Decision Date
    June 22, 1979
    Product Code
    KRB
    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
    KRB Probe, Thermodilution

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