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510(k) Data Aggregation

    K Number
    K993995
    Device Name
    VEIN ENTRY INDICATOR DEVICE (VEID)
    Manufacturer
    VASCULAR TECHNOLOGIES LTD.
    Date Cleared
    2000-02-14

    (82 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    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 Vein Entry Indicator Device (VEID) is used to indicate the location of a vein, including indication of vein entry, vein double puncture, vein re-entry and vein exit of an I.V. catheter system needle.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "Vein Entry Indicator Device (VEID)". It confirms the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, or performance data.

    Therefore, I cannot provide the requested information. The letter only approves the marketing of the device based on its substantial equivalence. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data.

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