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    K Number
    K162453
    Device Name
    13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
    Manufacturer
    Pan Medical Ltd.
    Date Cleared
    2016-11-01

    (61 days)

    Product Code
    NDN, HRX
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pan Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    8G InterV Kyphoplasty Catheter, 11G InterV Kyphoplasty Catheter (Mini), 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Flex) are intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).
    Device Description
    Both the predicate and the subject InterV Kyphoplasty Catheters are designed for use in balloon kyphoplasty; they come as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component.
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