LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962577
    Device Name
    ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    1997-08-21

    (416 days)

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

    ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER

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

    The multiple-lumen catheter permits venous access to the central circulation. The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.

    Device Description

    Quad-Lumen Central Venous Catheter

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ARROWgard Blue™ Quad-Lumen Central Venous Catheter). This document does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for the specific information regarding a study and acceptance criteria based on this input. It primarily deals with the regulatory clearance process and substantial equivalence, not the detailed technical and clinical validation study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1