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    K Number
    K980977
    Device Name
    PIOLAX HYDROPHILIC GUIDEWIRE
    Manufacturer
    PIOLAX MEDICAL DEVICES, INC.
    Date Cleared
    1998-10-27

    (225 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    PIOLAX MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Piolax Hydrophilic Guidewire is indicated for use for introduction and positioning of catheters within the peripheral vasculature in vascular diagnostic and therapeutic applications, particularly for arterial and venous applications in the cardiac, cerebral, and abdominal regions. The Guidewire is contraindicated for use in coronary vessels.
    Device Description
    The Piolax Hydrophilic Guidewire is a tapered wire. composed of stainless steel or Ni-Ti alloy that is coated with a hydrophilic polymer. The hydrophilic polymer is composed of polyvinyl pyrrolidone and benzoyl peroxide. The Guidewire is provided with one of three differently shaped hydrophilic polymer-coated tips (i.e., straight, angled, J-shaped). The standard wire diameters are 0.58 mm, 0.72 mm, 0.79 mm, and 0.86 mm. The range for length of guidewires is 450 to 3,000 mm.
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