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510(k) Data Aggregation

    K Number
    K182835
    Device Name
    WOLF Thrombectomy Device
    Manufacturer
    Date Cleared
    2019-03-27

    (169 days)

    Product Code
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    880 Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WOLF Thrombectorny Device is indicated for the nonsurgical removal of emboli and thrombi from arterial blood vessels in the peripheral vasculature.
    Device Description
    The WOLF Thrombectomy Device is comprised of two single lumen variable stiffness catheters (WOLF Inner & Outer) designed for use in removing clot from arterial peripheral vessels. The WOLF inner catheter is attached to the weave which when pulled, inqests the clot into the WOLF outer catheter. The WOLF device is delivered through a quide catheter that has an inner diameter of at least 0.068″. Both WOLF catheters have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The WOLF inner catheter has two radiopague marker bands. The distal marker is used to indicate the tip of the catheter during tracking. The proximal marker is used to indicate how far the physician should pull back the GC prior to pulling. The outer catheter has a distal radiopaque marker band to indicate its distal tip during tracking and pulling. The weave also has a radiopaque polymer cuff that allows for visualization of the weave movement.
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