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510(k) Data Aggregation

    K Number
    K993694
    Device Name
    MIKRO-TIP ANGIOGRAPHIC CATHETER
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Date Cleared
    2000-03-01

    (120 days)

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

    MIKRO-TIP ANGIOGRAPHIC CATHETER

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

    The Millar Angiographic catheter is designed to provide high fidelity pressure readings and deliver radiopaque contrast medium to selected sites in the vascular system.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Mikro-Tip Angiographic Catheter and does not contain the detailed study information requested. The letter states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the information requested in the prompt based on the provided document. The document only confirms the FDA clearance for the device and its intended use, but it does not include details on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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