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

    PLACEMENT-PLUS

    K Number: K003642 · Decision Dec 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    8
    Review Days
    23

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    Basic Information

    Device Name
    PLACEMENT-PLUS
    K Number
    K003642
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Catheter Innovations, Inc.
    Date Received
    November 27, 2000
    Decision Date
    December 20, 2000
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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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
    K993860 CATHETER INNOVATIONS IMPLANTABLE PORT
    K991897 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