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510(k) Data Aggregation

    K Number
    K182835
    Device Name
    WOLF Thrombectomy Device
    Manufacturer
    880 Medical, LLC
    Date Cleared
    2019-03-27

    (169 days)

    Product Code
    QEW,DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K142870,K143563
    Why did this record match?
    Device Name :

    WOLF Thrombectomy Device

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain the specific information required to complete the table and answer the questions related to the acceptance criteria and study details for the WOLF Thrombectomy Device. The document is primarily an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to predicate devices but does not elaborate on specific acceptance criteria and detailed study results in the structured format requested.

    The text mentions that "The objectives, as well as the acceptance criteria for success, were met" in the Animal Testing section, but it does not specify what those criteria were. It also describes that "Bench studies indicate that the 880 Medical WOLF Thrombectomy Device performs as intended" and lists various types of performance testing, but it does not provide the quantitative results or acceptance criteria for each test.

    Therefore, I cannot provide the requested table and detailed answers based solely on the input provided.

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