Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070630
    Date Cleared
    2007-08-31

    (177 days)

    Product Code
    Regulation Number
    880.5440
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE

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

    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow requlator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

    Device Description

    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow requlator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the Health Line International Corporation's IV Solution Administration Set with Check Valve. They do not contain information about acceptance criteria or a study proving that a device meets such criteria.

    The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria through a study as would be detailed for an AI/ML medical device.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1