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510(k) Data Aggregation

    K Number
    K161967
    Device Name
    FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
    Date Cleared
    2017-01-27

    (193 days)

    Product Code
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Callisyn Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FluidiTube® 2.7F Infusion Micro Catheter is intended to facilitate infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels and all coronary vessels. It is also intended for drug infusion in intra-arterial therapy and embolic materials for hemostasis. The FluidiTube® 2.7F Infusion Micro Catheter is not to be used in cerebral blood vessels.
    Device Description
    The FluidiTube® 2.7F Infusion Micro Catheter is a tapered 2.7F/2.9F single lumen catheter with a luer lock hub designed to facilitate the access of distal vasculature over a guidewire. The FluidiTube® has a semi-rigid proximal shaft that becomes progressively more flexible towards the distal end. The shaft is reinforced with braided stainless steel wire for kink resistance. The inner lumen is lined with a lubricious material to facilitate the movement of a guidewire. The outer surface of the catheter has a hydrophilic coating that becomes lubricious when wet with saline or blood. The FluidiTube® catheter is introduced to the target location through a guiding catheter 0.038" (0.97 mm) or larger and is compatible with 0.021" (0.53 mm) guidewires or smaller. Device configurations consist of one profile size (2.7F) with two different usable lengths (110cm, 130cm). The final device is packaged in a Tyvek pouch and sterilized by ethylene oxide (EO). The device is for single use only.
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