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

    PRO-LINE CT (BASIC TRAY) MODEL MR28036101

    K Number: K093309 · Decision Nov 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    7
    Review Days
    33

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    Basic Information

    Device Name
    PRO-LINE CT (BASIC TRAY) MODEL MR28036101
    K Number
    K093309
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medcomp ( Medical Components)
    Date Received
    October 22, 2009
    Decision Date
    November 24, 2009
    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 Medcomp ( Medical Components)

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