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510(k) Data Aggregation

    K Number
    K212288
    Device Name
    Minjie Catheter System
    Manufacturer
    Date Cleared
    2022-06-02

    (316 days)

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

    Kai Medtech, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Minjie Catheter System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
    Device Description
    The Minjie Catheter System consists of the Minjie Catheter, Introducer Peel Away Tool and packaging hoop with Elbow Flush Luer. The Minjie Catheter is a single lumen. flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the catheter is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating, to reduce friction during intravascular use. The Minjie Catheter System dimensions are included in the individual device label. The devices are supplied sterile and are intended for single use only.
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