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510(k) Data Aggregation

    K Number
    K100365
    Device Name
    FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2010-05-20

    (97 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV

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

    The Farrell Valve is a reservoir system intended to allow the evacuation of excess gas(gastric distention/bloating) and enteral feeding formula from the stomach of patients receiving enteral formula via feeding tubes and sets. Farrell Valve with CORFLO ANTI IV Connectors is for use with pediatric patients.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "FARRELL VALVE with CORFLO® ANTI IV Connectors". It does not contain information about acceptance criteria, study details, or device performance metrics typically found in a clinical study report or a summary of safety and effectiveness.

    Therefore, I cannot provide the requested information from this document. This letter primarily certifies that the device is substantially equivalent to a predicate device and can be legally marketed, subject to general controls and existing regulations.

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