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510(k) Data Aggregation

    K Number
    K992940
    Device Name
    LEMAITRE BALLOON CATHETER WITH IRRIGATION
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-02-22

    (175 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K992940
    Why did this record match?
    Device Name :

    LEMAITRE BALLOON CATHETER WITH IRRIGATION

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

    The LeMaitre Balloon Catheter with Irrigation is indicated for the extraction of emboli and thrombi from the peripheral arterial system and also may be used for infusion of fluids.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA to a medical device manufacturer for a LeMaitre Balloon Catheter with Irrigation, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not present any performance study data, acceptance criteria, sample sizes, expert qualifications, or other details typically found in a clinical or performance study report.

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