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510(k) Data Aggregation

    K Number
    K021481
    Device Name
    BRESAGEN CATHETER, MODEL CS-3000
    Manufacturer
    BRESAGEN, INC.
    Date Cleared
    2002-08-06

    (90 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For injection of material into, or removal of material from, the mendou over I or any intracranial procedures. This device is not intended for implant. This device is ETO sterilized and intended for one time use only.

    Device Description

    Bresagen Catheter, Model CS-3000

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a medical device (Bresagen Catheter) and does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. It primarily focuses on the regulatory clearance process and the device's intended use.

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