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510(k) Data Aggregation

    K Number
    K992368
    Device Name
    LEMAITRE EMBOLECTOMY CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    1999-12-09

    (147 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 EMBOLECTOMY CATHETER

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

    The LeMaitre Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter from the FDA for a medical device called the "LeMaitre Embolectomy Catheter." This type of document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert details for AI/device performance evaluation.

    510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While manufacturers submit data to support their claims, the detailed study information as requested is not typically included in the final clearance letter itself. These letters acknowledge the submission and state the FDA's finding of substantial equivalence.

    Therefore, I cannot provide the requested information from the provided text.

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