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510(k) Data Aggregation

    K Number
    K051655
    Device Name
    ANGIODYNAMICS, INC., MICRO ACCESS KITS
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    2005-09-12

    (83 days)

    Product Code
    DQR,DQX,DRC,DYB
    Regulation Number
    870.1300
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANGIODYNAMICS, INC., MICRO ACCESS KITS

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

    The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain information regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications. It only states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

    Therefore, I cannot fulfill your request for the specific information outlined.

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