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510(k) Data Aggregation

    K Number
    K051248
    Device Name
    VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
    Manufacturer
    VYGON CORP.
    Date Cleared
    2005-10-27

    (164 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This introducer kit is intended for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a scanned document from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

    The document is a clearance letter stating that the Vygon Micro-Access Safety Introducer Kit has been found substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided text.

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