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510(k) Data Aggregation

    K Number
    K200627
    Device Name
    GlidePath 10F Long-Term Dialysis Catheter
    Manufacturer
    C R Bard, Inc
    Date Cleared
    2020-06-22

    (104 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    C R Bard, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.
    Device Description
    The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.
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