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

    TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY

    K Number: K030983 · Decision Apr 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY
    K Number
    K030983
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Deltec, Inc.
    Date Received
    March 28, 2003
    Decision Date
    April 25, 2003
    Product Code
    MSD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSD Catheter, Hemodialysis, Implanted

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    Other Clearances by Deltec, Inc.

    K Number Device Name
    K031361 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
    K022221 TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
    K021999 GRIPPER PLUS NEEDLE
    K020655 DELTEC INSULIN INFUSION PUMP AND ACCESSORIES