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510(k) Data Aggregation

    K Number
    K093026
    Device Name
    FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2010-02-24

    (148 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER

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

    This device is intended to facilitate placing a catheter through the skin into a vein or artery.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided document is a 510(k) clearance letter for a medical device (Footprint Medical 1.9 Fr PICC Introducer). This type of document does not contain information related to acceptance criteria, device performance studies, or AI/software validation studies.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device already on the market. It typically involves comparing the device's technological characteristics and intended use to a legally marketed predicate device, and often includes bench testing to ensure the device meets basic safety and performance standards relevant to its design. It does not typically include clinical trials or detailed performance studies with ground truth establishment in the way that AI-powered devices would require.

    Therefore, I cannot provide the requested information based on the text provided.

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