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510(k) Data Aggregation

    K Number
    K023740
    Date Cleared
    2003-05-13

    (187 days)

    Product Code
    Regulation Number
    880.5200
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYREX PRE-FILLED SYRINGE

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

    Flushing of IV catheters and IV tubing only. Prior to and after administration of intermittent medication, entirely flush the catheter and or tubing with Heparin Lock Flush Solution, either USP 10 Units/mL or USP 100 Units/mL. Use in accordance with any warning or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

    Device Description

    Syrex Pre-Filled Syringe, Heparin Lock Flush Solution, USP 10 and 100 Units/ml

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device, the Syrex Pre-Filled Syringe, Heparin Lock Flush Solution. It is a regulatory approval document and does not contain information about acceptance criteria, device performance studies, or clinical trial data as typically found in a scientific study or clinical report.

    Therefore, I cannot provide the requested information based on the input text. The input text primarily deals with:

    • General regulatory information regarding medical device clearance.
    • Confirmation of substantial equivalence to a predicate device.
    • Instructions for compliance with FDA regulations.
    • Indications for Use statement for the device.

    To address your request, information from a different type of document, such as a clinical study report, a scientific publication, or the device's design validation documentation, would be necessary.

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