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510(k) Data Aggregation

    K Number
    K172315
    Device Name
    Straub Endovascular System
    Manufacturer
    Straub Medical AG
    Date Cleared
    2018-04-12

    (254 days)

    Product Code
    MCW, DQX
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    Straub Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When operated with a Rotarex S single use catheter, the Straub Endovascular System is intended for use as an atherectomy device and to break up and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, pulmonary, iliac or renal vasculature.
    Device Description
    The Straub Endovascular System consists of: - Rotarex®S catheter set which includes a Rotarex®S catheter, guidewire, collecting bag and drape. ● All are provided sterile and are for single use - . Drive System, consisting of the Control Unit, Motor and Foot switch. The Drive System serves to drive and control the rotational catheters. Rotarex S is an over-the-wire, percutaneous catheter. The catheter consists of a flexible braided shaft, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied guidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40.000-60.000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with facets at its foremost tip, which when rotating, serve to abrade occluding material lying in front of it. Concomitantly, the rotation of the catheter head creates a vortex in the blood which assists to further erode occluding material from the vessel lumen. The detached material is aspirated into the side openings of the overlying cylinders where it is further broken down within the head and then carried through the inner lumen into a collecting bag outside of the body.
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