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510(k) Data Aggregation

    K Number
    K980919
    Device Name
    ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    1998-03-31

    (20 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

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

    The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.

    Device Description

    All Silicone 2-Way Foley Balloon Catheter All Silicone 3-Way Foley Balloon Catheter All Silicone Nelation Catheter

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth methods.

    Therefore, I cannot answer the questions based on the input provided. The document outlines regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results.

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