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

    PORT-A-CATH IMPLANTABLE CATHETER SYSTEM

    K Number: K864552 · Decision Mar 31, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    129
    Review Days
    132

    Basic Information

    Device Name
    PORT-A-CATH IMPLANTABLE CATHETER SYSTEM
    K Number
    K864552
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    PHARMACIA, INC.
    Date Received
    November 19, 1986
    Decision Date
    March 31, 1987
    Product Code
    LLD
    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
    LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal

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