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510(k) Data Aggregation

    K Number
    K142116
    Device Name
    LLD EZ
    Manufacturer
    SPECTRANETICS, INC.
    Date Cleared
    2014-08-12

    (8 days)

    Product Code
    DRB
    Regulation Number
    870.1380
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LLD EZ

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

    The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device (LLD EZ catheter stylet) and does not contain the information requested about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which means it has the same intended use and technological characteristics as a device already on the market, or if it has different characteristics, these do not raise new questions of safety and effectiveness.

    To answer your questions, I would need to analyze a different type of document, such as a summary of safety and effectiveness data (often submitted with a 510(k)) or a clinical study report. The provided text is solely the FDA clearance letter and an "Indications for Use" statement.

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