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510(k) Data Aggregation

    K Number
    K211110
    Device Name
    Agile Devices Angler Steerable, Deflectable Microcatheter
    Date Cleared
    2022-01-07

    (268 days)

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

    Agile Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Agile Devices Angler™ Steerable, Deflectable Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled infusion of diagnostic agents and delivery of embolic or therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
    Device Description
    The Agile Devices Angler™ Steerable, Deflectable Microcatheter is a variable stiffness, single lumen microcatheter designed to access small tortuous vasculature. It has a steerable articulating deflectable tip and has a hydrophilic polymer coating over the distal 80cm which gives lubricity when wet. Tip deflection is controlled using a manual steering mechanism / handle external to the body. On-plane bi-directional tip deflection is achieved via coaxial movement of the inner versus the outer shaft which bends a distal covered flat wire. Material injection is achieved via syringe connection to the proximal end of the catheter. The Agile Devices Angler™ Steerable, Deflectable microcatheter has a maximum outside diameter of 0.0394" (3F). It has an inside diameter of 0.021" and has two radiopaque marker bands on the distal tip and at the deflection point to facilitate fluoroscopic visualization. It is compatible with guiding catheters with I.D. down to 0.047". The microcatheter lumen is compatible with steerable guidewires up to 0.018", and particles up to 500um or embolic spheres up to 700μm, with a burst pressure rating up to 1000 psi.
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