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510(k) Data Aggregation

    K Number
    K182918
    Device Name
    Ballast 088 Long Sheath
    Manufacturer
    Balt USA LLC
    Date Cleared
    2019-03-21

    (153 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Balt USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
    Device Description
    The Ballast 088 Long Sheath is a sterile, single lumen, variable stiffness Guide Catheter / Long Sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature. The Ballast 088 Long Sheath consists of a lubricous inner liner made from Polytetrafluoroethylene (PTFE) reinforced by a stainless steel coil over the inner liner and stainless steel braid partially covering the inner coil layer. The outer jacket consists of thermoplastics ranging from thermoplastic polyurethane (TPU), polyether block amide (Pebax), and polyamide 12. The distal section of the Ballast 088 Long Sheath is coated with hydrophilic coating to provide lubricity during use. A Platinum/Iridium marker band is placed at the distal end of the catheter for maximum radiopacity. An introducer sheath, 9F hemostasis valve, 8F hemostasis valve adapter and a dilator are also provided with the device.
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