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510(k) Data Aggregation

    K Number
    K981080
    Device Name
    SCOOP 1
    Manufacturer
    TRANSTRACHEAL SYSTEMS
    Date Cleared
    1998-06-17

    (85 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SCOOP 1

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

    Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia

    Device Description

    SCOOP I, Transtracheal Catheter

    AI/ML Overview

    The provided document is a 510(k) premarket notification approval letter for the SCOOP I Transtracheal Catheter. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

    The letter from the FDA primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to pre-amendment devices and can proceed to market. It mentions general controls provisions, potential additional controls for Class II/III devices, and compliance with Good Manufacturing Practice.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, expert qualifications, etc.) from the provided text. This information would typically be found in the 510(k) submission itself or a separate clinical/performance study report, neither of which is included in this document.

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