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510(k) Data Aggregation

    K Number
    K162384
    Device Name
    TrailBlazer Angled Support Catheter
    Manufacturer
    Medtronic Vascular, Inc.(formerly ev3 Inc.)
    Date Cleared
    2016-09-22

    (28 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medtronic Vascular, Inc.(formerly ev3 Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. The TrailBlazer™ angled support catheters are intended to guide and support a guide wire during access of the vasculature, to allow for guide wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
    Device Description
    The TrailBlazer™ angled support catheter is an over-the-wire (OTW) single lumen catheter with a tapered angled distal tip. The catheter system is compatible with 0.36 mm (0.014in.), 0.46 mm (0.018 in.), or 0.89 mm (0.035 in.) guidewires. The support catheter has working lengths of 65 cm. 90 cm. 135 cm. and 150 cm depending on the model. All models are compatible with a 4 Fr introducer sheath. The manifold provides proximal access to the lumen which transitions to the catheter shaft and terminates at the angled distal tip. The lumen is used to pass the catheter over a guidewire. The manifold is constructed from elastomer and molded to the catheter proximal shaft. The guidewire compatible diameter and length are marked on the strain relief that is clipped to the manifold post molding. The multi-layer elastomer catheter shaft is designed with a stainless steel braided mesh. Three radiopaque markers starting at the distal tip aid in positioning the catheter. The distal tip of the catheter is molded to a predetermined angle to optimize vessel subselection with a guidewire. The distal 40cm portion of the catheter is coated with a hydrophilic coating. Finished catheters are packaged in hoops, sealed in pouches and provided in 5-pack cartons with an IFU.
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