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510(k) Data Aggregation

    K Number
    K024126
    Device Name
    CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    2003-01-14

    (29 days)

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

    Indicated as 10" (or up to 48") CLEAR (or BRAIDED) CONTRAST MEDIA INJECTION LINE WITH ROTATOR, for use in Cardiac catheterization and radiology special procedure

    Device Description

    High Pressure Tubing (intravascular administration set)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Abbott Laboratories for a device named "High Pressure Tubing." The letter states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain any information about acceptance criteria, device performance testing, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC or standalone).

    Therefore, I cannot answer your request based on the provided text. The document is solely an FDA clearance letter and does not include the technical details of the device's validation or testing.

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