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

    SEA - PORT INFUSION SET

    K Number: K880297 · Decision Feb 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    7
    Review Days
    25

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    Basic Information

    Device Name
    SEA - PORT INFUSION SET
    K Number
    K880297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Harbor Medical Devices, Inc.
    Date Received
    January 25, 1988
    Decision Date
    February 19, 1988
    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 Harbor Medical Devices, Inc.

    K Number Device Name
    K884628 HARBORIN CENTRAL VENOUS CATHETER
    K890518 SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM
    K882657 HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT
    K881884 HARBOR CENTRAL VENOUS CATHETER
    K882190 S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM
    K874414 HYPODERMIC NEEDLES, SINGLE LUMEN