LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061733
    Device Name
    ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    2006-08-24

    (65 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K073200
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

    Device Description

    ANGIODYNAMICS Soft-Vu and ANGIODYNAMICS Mariner Hydrophilic Coated Catheters

    AI/ML Overview

    The provided text is a 510(k) summary for the AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters. This document is a regulatory clearance, not a study report detailing acceptance criteria and performance data.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study results cannot be found in the provided text.

    The document only states that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is typically based on design, materials, and intended use, and does not generally involve a detailed performance study against specific acceptance criteria in the way a clinical trial or algorithm validation would.

    In summary, the input text does not contain the information needed to answer the prompt.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1