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

    STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED

    K Number: K905852 · Decision Apr 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    45
    Review Days
    113

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    Basic Information

    Device Name
    STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED
    K Number
    K905852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Strato Medical Corp.
    Date Received
    December 27, 1990
    Decision Date
    April 19, 1991
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Strato Medical Corp.

    K Number Device Name
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