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510(k) Data Aggregation

    K Number
    K203069
    Device Name
    HydroMID
    Manufacturer
    Access Vascular Inc.
    Date Cleared
    2021-02-08

    (122 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Access Vascular Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydroMID is indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administrations, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L. HydroMID is rated for a Maximum Power Injection Flow Rate of 6mL/sec.
    Device Description
    The HydroMID catheter is a short term (< 30 days) peripheral venous access device with a single 4F outer diameter lumen that is 20 cm in length. Midlines are usually placed in an arm vein such as the basilic, brachial, or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments. The HydroMID catheter is comprised of radiopaque, hydrophilic base with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. The catheter has a maximum power injection flow rate of 6ml/sec. HydroMID has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
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