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510(k) Data Aggregation

    K Number
    K973199
    Device Name
    AMSINO SUCTION CATHETER
    Manufacturer
    AMSINO INTL., INC.
    Date Cleared
    1997-09-10

    (15 days)

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

    AMSINO SUCTION CATHETER

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

    Amsino Suction Catheter, tracheobronchial, is to be used to aspirate liquids or semisolids from a patient's upper airway.

    Device Description

    AMSINO® Suction Catheter

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "AMSINO® Suction Catheter." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

    However, the letter does not contain any information regarding acceptance criteria or a study proving the device meets those criteria. The content is purely administrative, focusing on the regulatory clearance process.

    Therefore, I cannot provide the requested information from the given text.

    To be clear:

    1. Table of acceptance criteria and reported device performance: Not available.
    2. Sample size and data provenance: Not available.
    3. Number and qualifications of experts for ground truth: Not available.
    4. Adjudication method for test set: Not available.
    5. MRMC comparative effectiveness study: Not available.
    6. Standalone performance study: Not available.
    7. Type of ground truth used: Not available.
    8. Sample size for training set: Not available.
    9. How ground truth for training set was established: Not available.
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