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

    Dignity Dual Port

    K Number: K153238 · Decision Mar 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    7
    Review Days
    127

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Dignity Dual Port
    K Number
    K153238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medcomp ( Medical Components)
    Date Received
    November 9, 2015
    Decision Date
    March 15, 2016
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LJT), ordered by most recent decision date.

    FLEXI-PORT™ Power Injectable Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Medcomp ( Medical Components)

    K Number Device Name
    K162389 Medcomp Vessel Dilator
    K143238 C3 Wave
    K132177 MEDCOMP GEN III POWER INJECTABLE PORT
    K130897 MEDCOMP VASCU-PICC WITH VALVE
    K110424 DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
    K093309 PRO-LINE CT (BASIC TRAY) MODEL MR28036101