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

    MEDCOMP GEN III POWER INJECTABLE PORT

    K Number: K132177 · Decision Dec 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    7
    Review Days
    150

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    Basic Information

    Device Name
    MEDCOMP GEN III POWER INJECTABLE PORT
    K Number
    K132177
    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
    July 15, 2013
    Decision Date
    December 12, 2013
    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 Medcomp ( Medical Components)

    K Number Device Name
    K162389 Medcomp Vessel Dilator
    K153238 Dignity Dual Port
    K143238 C3 Wave
    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