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510(k) Data Aggregation

    K Number
    K113162
    Device Name
    SLIDEWIRETM(TRADEMARK PENDING)
    Manufacturer
    Date Cleared
    2012-07-20

    (268 days)

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

    ACME-MONACO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Acme Monaco Slidewire™ (Trademark Pending) is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.
    Device Description
    The Acme Monaco Hydrophilic Guidewire, hereafter referred to as Acme Monaco Slidewire®, is composed of a Nickel Titanium (aka NiTi or Nitinol) core wire, jacketed with a durable polymer that is receptive to a coating. The polymer resin is blended with Tungsten, a radiopaque metal and affixed to the core wire via adhesive. The jacketed core wire is then coated with a hydrophilic coating. The Acme Monaco Slidewire of can be constructed to various lengths, diameters and distal configurations, is a single-use device and provided sterile for commercial distribution.
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