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510(k) Data Aggregation

    K Number
    K223258
    Device Name
    TNI Clear-Guard™ 3 angled breathing filter (1545020)
    Manufacturer
    Intersurgical Ltd.
    Date Cleared
    2023-06-15

    (237 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Intersurgical Ltd.

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

    To be used only as part of the softFlow® 50 device to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. The filter should be positioned in a non-humidified gas flow.

    Device Description

    Clear-GuardTM 3 angled Breathing Filter, Model #1545020

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted on a medical device. The document is a 510(k) clearance letter from the FDA for a breathing circuit bacterial filter, but it does not detail the technical performance or validation studies of the device itself. Therefore, I cannot generate the requested table and paragraphs based on this input.

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