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510(k) Data Aggregation

    K Number
    K991254
    Device Name
    QS DELIVERY SYSTEM
    Manufacturer
    SUB-Q, INC.
    Date Cleared
    1999-08-23

    (132 days)

    Product Code
    KYZ
    Regulation Number
    880.6960
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QS DELIVERY SYSTEM

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

    The QS Delivery System is intended for the delivery of hemostatic agents that can be mechanically mixed and delivered to bleeding sites.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "QS Delivery System." This document is a regulatory approval letter and an "Indications for Use Statement." It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the given text. The document confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed, but does not detail the scientific studies or performance data that would typically be included in a technical report or submission summary.

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