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510(k) Data Aggregation

    K Number
    K120008
    Device Name
    MEDLINE HIGH PRESSURE INJECTION TUBING
    Manufacturer
    MEDLINE, INDUSTRIES, INC.
    Date Cleared
    2012-08-17

    (227 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE HIGH PRESSURE INJECTION TUBING

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

    The Medline High Pressure Tubing is indicated for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye or saline.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance as requested. The document is an FDA 510(k) clearance letter for a medical device called "Medline High Pressure Tubing," indicating its substantial equivalence to a predicate device and specifying its intended use. It does not include any performance data or study design details.

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