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510(k) Data Aggregation

    K Number
    K043140
    Device Name
    EXPRESS AND OASIS CHEST DRAIN
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2004-12-08

    (23 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXPRESS AND OASIS CHEST DRAIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • To evacuate air and/or fluid from the chest cavity or mediastinum. .
    • To help re-establish lung expansion and restore breathing dynamics. .
    • To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for medical devices, specifically chest drains. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The letter acknowledges the company's "premarket notification of intent to market" and states that the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory clearance based on substantial equivalence, not a clinical study proving pre-defined performance metrics.

    Therefore, I cannot provide the requested information from the provided text as it does not contain the details of a study with acceptance criteria and device performance.

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