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510(k) Data Aggregation

    K Number
    K210185
    Device Name
    CardioCurve Steerable Sheath
    Manufacturer
    Talon Surgical
    Date Cleared
    2021-07-23

    (179 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Talon Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Talon Surgical CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The Talon Surgical CardioCurve Steerable Sheath is a 8.5F sterile, single-use, catheter introducer used for the introduction, withdrawal, and exchange of guidewires and catheters while minimizing blood loss. It is available in lengths of 40, 61, 71 or 82 cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, market cleared guidewire (K935170). A side port with three-way stopcock allows blood aspiration, fluid infusion, and pressure monitoring. An integrated Tuohy Borst adaptor is designed to hold a guidewire or catheter in place. The steerable sheath features distal side holes to facilitate aspiration and minimize cavitation, and a stainless-steel ring for visualization under fluoroscopy. The handle is equipped with two linked rotating dials used to deflect the tip clockwise and counterclockwise 180°. The CardioCurve Steerable Sheath shaft is made from barium loaded Pebax and Nylon and includes a radiopaque tip marker for visibility under fluoroscopy and is braided, except for the distal tip, for kink resistance; the handle is made of ABS. The dilator is made of HDPE that is barium loaded for visibility under fluoroscopy The CardioCurve Steerable Sheath Dilator can be used with a curved transseptal St. Jude Medical BRKTM type needle with stylet if indicated on the package label.
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