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

    PRO-PICC CT

    K Number: K092347 · Decision Sep 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    40
    Review Days
    43

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    Basic Information

    Device Name
    PRO-PICC CT
    K Number
    K092347
    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
    Date Received
    August 4, 2009
    Decision Date
    September 16, 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

    K Number Device Name
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    K091954 MICRO-STICK SET
    K091953 PRO-PICC
    K090394 VALVED TEARWAY INTRODUCER
    K091586 VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN
    K091466 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
    K081775 THE MEDCOMP .010 VASCULAR GUIDEWIRES
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