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510(k) Data Aggregation

    K Number
    K972258
    Device Name
    HI-CARE CLOSED SUCTION SYSTEM
    Manufacturer
    MALLINCKRODT MEDICAL
    Date Cleared
    1997-12-29

    (195 days)

    Product Code
    BSY
    Regulation Number
    868.6810
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HI-CARE CLOSED SUCTION SYSTEM

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

    This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the "Hi-Care Closed Suction System." It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

    Therefore, I cannot provide the requested information. The provided text is a regulatory approval document, not a clinical study report or a performance evaluation.

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