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510(k) Data Aggregation

    K Number
    K223791
    Device Name
    TalWire
    Manufacturer
    Embrace Medical Ltd.
    Date Cleared
    2023-07-14

    (207 days)

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

    Embrace Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TalWire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. The TalWire is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The TalWire is a family of vascular access mandrel guidewires. The TalWire is available in various sizes: between 40 to 80 cm in length and in the 0.018" diameter range. The TalWire is available with Nitinol (NiTi) cores and Stainless Steel coils. The TalWire consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A microcoil is wound with a lumen that is then placed over the tapered distal end of the coil is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The TalWire includes an articulatable tip at the distal end of the guidewire. The finished guidewire is placed in a protective polymer dispenser hoop in a labeled Tyvek pouch. The TalWire is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
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