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510(k) Data Aggregation

    K Number
    K192283
    Device Name
    MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
    Manufacturer
    Medron, LLC
    Date Cleared
    2020-05-06

    (258 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medron, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDRON Vessel Dilator is designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
    Device Description
    The MEDRON Vessel Dilator is a dilator consisting of a radiopaque HDPE (high density polyethylene) shaft with an overmolded HDPE Hub. The dilator comes in a variety of diameters ranging from 6F to 17.5F. It is also available in two models, a straight model and a stepped model. The straight model has a consistent diameter along the length of the shaft until it tapers at the distal tip. In the stepped model, the distal segment of the dilator shaft has a smaller diameter than the proximal segment as well as a taper at the distal tip.
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