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510(k) Data Aggregation

    K Number
    K072130
    Device Name
    PTFE PEEL AWAY MICROINTRODUCER
    Manufacturer
    INTROMED
    Date Cleared
    2007-10-31

    (90 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

    Not Found

    Device Description

    PTFE Peel Away Microintroducer

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study. It is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "PTFE Peel Away Microintroducer," confirming its substantial equivalence to a legally marketed predicate device. This letter primarily focuses on regulatory compliance and does not detail any technical performance studies performed on the device.

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