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510(k) Data Aggregation

    K Number
    K102439
    Device Name
    FUNNEL GUIDE CATHETER MODEL G1020608
    Date Cleared
    2012-01-12

    (504 days)

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

    LAZARUS EFFECT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Funnel Guide Catheter" is indicated for use in the peripheral and coronary vasculature for the introduction of interventional and/or diagnostic devices.
    Device Description
    The Lazarus Effect Funnel Guide Catheter" (Funnel Guide Catheter") is a single-lumen, variable-stiffness catheter with an atraumatic nitinol wire braided funnel distal tip to facilitate the passage of other interventional and/or diagnostic devices. Device dimensions and configuration are shown on the product label. The Funnel Guide Catheter" is compatible with introducer sheaths and guide catheters having an inner diameter of 6F or greater. A rotating hemostasis valve with side-arm adapter and a compatible guidewire may be used, but are not provided with the Funnel Guide Catheter™.
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