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510(k) Data Aggregation

    K Number
    K970657
    Device Name
    LMI THROMBECTOMY CATHETER
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1997-07-01

    (130 days)

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

    LMI THROMBECTOMY CATHETER

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

    The LMI Thrombectomy Catheter is intended for use in venous thrombectomy procedures for intra-operative removal of venous thrombus formations from veins.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the LMI Thrombectomy Catheter. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

    The letter is a regulatory approval document confirming market readiness based on substantial equivalence, not a detailed report of technical performance studies. Therefore, I cannot provide the requested information from the given text.

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