LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994196
    Device Name
    HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-02-10

    (59 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM

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

    The MicroPort 2 System is indicated for peripheral placement in the midarm, above the anticubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

    Device Description

    The Horizon Medical Products MicroPort 2 system consist of a low profile ellipsoidal port made of Titanium and an attachable Polyurethane catheter. The catheter is attached to the port body by placing the catheter and strain relief connector over the barbed stem (outlet tube) of the body. The port body is implanted in the mid-arm (above the elbow). Implantation in the mid-arm avoids the bend in the elbow, which could place the catheter under added stress. The catheter reaches the central venous circulation via either the basilic or axillary vein. The veins in the upper arm are larger and offer a less tortuous path to the central venous circulation, making insertion easier. Additionally, this catheter route lessens the danger of pneumothorax, hemopneumothorax, air embolism, as well as catheter shear (Note: Catheter does not pass between the clavicle and the first rib.).

    The MicroPort 2 Peripheral Access System is packaged without and with kit introducer components. The kit contains basic components required for percutaneous. The system is sterilized by ethylene oxide gas and is labeled as a sterile as well as a single use only device.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Horizon Medical Products Microport 2 Peripheral Access System. It asserts substantial equivalence to predicate devices and describes the device, its intended use, and general safety considerations, but does not contain acceptance criteria or a study proving the device meets specific performance criteria.

    Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria for a new device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1