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

    SET, INTRAVASCULAR

    K Number: K881975 · Decision Jul 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    14
    Review Days
    79

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    Basic Information

    Device Name
    SET, INTRAVASCULAR
    K Number
    K881975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Primrose Medical, Inc.
    Date Received
    May 11, 1988
    Decision Date
    July 29, 1988
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPA Set, Administration, Intravascular

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    K881976 CATHETER, INTRAVASCULAR
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