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510(k) Data Aggregation

    K Number
    K031282
    Device Name
    OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2003-08-05

    (105 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OptiLock Implantable Port is designed for patients who require repeated long-term access to the vascular system for intravascular injection or continuous infusion of filtids, medications, antiblotics, nutritionals, and the withdrawl of blood samples.

    Device Description

    OptiLock Implantable Port

    AI/ML Overview

    This is a 510(k) clearance letter for a medical device (OptiLock Implantable Port), not a study report. Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies.

    The FDA 510(k) clearance process determines "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety by meeting specific performance criteria.

    Therefore, I cannot provide the requested information from the given input.

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