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510(k) Data Aggregation

    K Number
    K130569
    Device Name
    ND NABIL DIB INFUSION CATHETER
    Date Cleared
    2013-11-15

    (256 days)

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

    Translational Research Institute

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ND Infusion Catheter is a multi-channel balloon catheter designed to isolate a specific vascular treatment region from biood flow while allowing infusion of physician-specified fluids into the target region.
    Device Description
    The ND Infusion Catheter is a multilumen (3) and multichannel (6) balloon catheter designed to isolate a specific treatment region from blood flow while directing infusion of fluids into the specified region. The catheter has a length of 135cm and diameter of 3F, and is intended to be used with a 6F or larger guide catheter along with a 0.014" rapid exchange guide wire for positioning the catheter in the desired region. The bifurcated proximal hub provides for the following functionality: 1) Balloon Port · Inflation of a compliant balloon to requlate blood flow during therapy infusion; target vessel diameter = 2.0 - 4.5 mm. · Balloon is prepared via a 3-way stopcock connection using a 10cc syringe and inflated using a 50:50 contrast/saline solution delivered via a 1cc syringe for precise inflation under fluoroscopic guidance. 2) Infusion Port · Infusion of a therapeutic agent into the vasculature through multiple fluid channels (each with diameter = 0.006"). · Physician-specified fluid is administered through the infusion port via a 1-way stopcock connection using a 1cc syringe. The catheter is designed with 3 shaft transitions. As a result, the catheter has 4 contiguous segments: PROXIMAL, MID, EXPANSION, and DISTAL. Radiopaque marker bands at each end of the balloon and at the distal tip allow for catheter positioning under fluoroscopic guidance.
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