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510(k) Data Aggregation

    K Number
    K082870
    Device Name
    VTI INTRAOPERATIVE DOPPLER SYSTEMS
    Manufacturer
    VASCULAR TECHNOLOGY INCORPORATED
    Date Cleared
    2008-10-28

    (29 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VTI INTRAOPERATIVE DOPPLER SYSTEMS

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

    The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.

    Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the "VTI Intraoperative Doppler Systems." It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter focuses on the regulatory clearance process, general controls, and compliance with federal statutes. It does not include details about specific performance metrics, studies, or clinical trial results that would typically be used to demonstrate acceptance criteria.

    Therefore, I cannot provide the requested information based on the text provided.

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