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510(k) Data Aggregation

    K Number
    K231179
    Device Name
    Slinky Catheter
    Manufacturer
    Anoxia Medical, Inc.
    Date Cleared
    2023-12-01

    (219 days)

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

    Anoxia Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Slinky Catheter is indicated for general intravascular use. including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents and therapeutic devices. It is not intended for use in coronary arteries.
    Device Description
    The Slinky® Catheter is a single lumen, variable stiffness catheter with a coil and braid reinforcement. It has a radiopaque marker at the distal tip for enhanced fluoroscopic visualization, a lubricious inner, and a hydrophilic coating on the distal 35 cm to enhance lubricity and vascular navigation. The Slinky® Catheter is provided sterile via Ethylene Oxide (EO) sterilization, non-pyrogenic, and is for single use only.
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