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510(k) Data Aggregation

    K Number
    K971411
    Device Name
    DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K
    Manufacturer
    BENTEC MEDICAL, INC.
    Date Cleared
    1997-06-03

    (48 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K

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

    The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

    Device Description

    Epistaxis Catheter

    AI/ML Overview

    The provided text details an FDA 510(k) clearance letter for the Vyker Silicone Epistaxis Catheter and its intended use. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the input document. The document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.

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