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510(k) Data Aggregation

    K Number
    K992934
    Device Name
    LEMAITRE VENOUS THROMBECTOMY CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-03-01

    (183 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LEMAITRE VENOUS THROMBECTOMY CATHETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LeMaitre Venous Thrombectomy Catheter is indicated for the removal of venous thrombi.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "LeMaitre Venous Thrombectomy Catheter". The letter primarily addresses the substantial equivalence of the device to legally marketed predicate devices and grants permission to market the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

    Therefore, I cannot provide the requested information based on the given text. The document is a regulatory approval letter, not a study report.

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