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510(k) Data Aggregation

    K Number
    K242392
    Device Name
    PATH BGC
    Manufacturer
    Crossroads Neurovascular, Inc.
    Date Cleared
    2025-05-09

    (270 days)

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

    Crossroads Neurovascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
    Device Description
    The PATH Balloon Guide Catheter (PATH BGC) is a dual coaxial lumen catheter consisting of an inner coil reinforced variable stiffness lumen and an outer braid reinforced variable stiffness lumen. A radiopaque marker is included at the tip of the catheter and at the distal and proximal ends of the balloon. A compliant balloon is mounted near the distal end of the catheter to provide vascular occlusion during angiographic procedures. The catheter has hydrophilic coating at the distal and proximal end. A bifurcated luer hub on the proximal end allows attachments for flushing and balloon inflation.
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