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510(k) Data Aggregation

    K Number
    K992941
    Device Name
    LEMAITRE BILIARY CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-01-12

    (134 days)

    Product Code
    LQR
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LEMAITRE BILIARY CATHETER

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

    The LeMaitre Biliary Catheter is indicated for the removal of stones and ductal debris.

    Device Description

    Not Found

    AI/ML Overview

    This document is correspondence from the FDA regarding a 510(k) premarket notification for the "LeMaitre Biliary Catheter." It is NOT a study report or a document describing acceptance criteria and device performance.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the provided text. The document only states that the device is deemed "substantially equivalent" to legally marketed predicate devices for its stated indications for use (removal of stones and ductal debris).

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