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510(k) Data Aggregation

    K Number
    K050456
    Device Name
    MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    2005-06-17

    (114 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM

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

    The MEDRAD Avanta™ Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter from the FDA to Medrad, Inc. for their Avanta Fluid Management Injection System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the 510(k) submission itself or in a summary of safety and effectiveness, neither of which is provided here.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The provided text only states that the device is substantially equivalent to legally marketed predicate devices for the indications for use.

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