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

    CATHETER INNOVATIONS IMPLANTABLE PORT

    K Number: K991897 · Decision Oct 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    CATHETER INNOVATIONS IMPLANTABLE PORT
    K Number
    K991897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Catheter Innovations, Inc.
    Date Received
    June 4, 1999
    Decision Date
    October 21, 1999
    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 Catheter Innovations, Inc.

    K Number Device Name
    K021704 VAXCEL PICC WITH PASV VALVE TECHNOLOGY
    K010349 DUAL LUMEN MIDLINE CATHETER
    K003642 PLACEMENT-PLUS
    K993860 CATHETER INNOVATIONS IMPLANTABLE PORT
    K981382 PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS
    K981368 PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS
    K980127 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT