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510(k) Data Aggregation

    K Number
    K983480
    Device Name
    BPOS-IVAD STABILIZER
    Manufacturer
    BPOS, INC.
    Date Cleared
    1998-11-23

    (52 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.

    Device Description

    The BPOS-IVAD STABILIZER is a non-invasive two-pronged device used to stabilize an area of the skin over an implanted vascular access device while performing a procedure on that immediate area.

    AI/ML Overview

    The provided text is a 510(k) summary for the BPOS-IVAD Stabilizer, dated November 23, 1998. It explicitly states under section "6. DEVICE TESTING" that "No testing has been done."

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study or testing was conducted or reported in this submission. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on performance testing.

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