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510(k) Data Aggregation

    K Number
    K043582
    Device Name
    OCEAN CHEST DRAIN
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2005-01-21

    (24 days)

    Product Code
    KDQ
    Regulation Number
    880.6740
    Type
    Special
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OCEAN 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

    The provided text is a U.S. FDA 510(k) clearance letter for the "Ocean Chest Drain" device. This document confirms the device's substantial equivalence to a predicate device and its approval for marketing.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or similar details that would typically be found in a study report or clinical trial summary.

    The letter is a regulatory approval and does not describe the specific tests or data that led to that approval. It only states that the FDA "reviewed your Section 510(k) premarket notification" and found the device "substantially equivalent."

    Therefore, I cannot provide the requested information based on the given input text.

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