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510(k) Data Aggregation

    K Number
    K981630
    Device Name
    VYGON DOUBLE LUMEN UMBILICAL CATHETER
    Manufacturer
    SCHIFF & CO.
    Date Cleared
    1998-10-01

    (147 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VYGON DOUBLE LUMEN UMBILICAL CATHETER

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

    Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.

    Device Description

    Double Lumen Umbilical Catheter

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Vygon Double Lumen Umbilical Catheter" (K981630). It is a regulatory approval document and not a scientific study report.

    Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document. This letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not provide the specific performance data or the study design used to make that determination.

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