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510(k) Data Aggregation

    K Number
    K131079
    Device Name
    CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
    Date Cleared
    2013-08-01

    (106 days)

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

    CREGANNA MEDICAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Creganna-Tactx Steerable Sheath Set is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The Creganna-Tactx Steerable Sheath is a stainless steel braided steerable sheath which is compatible with EP Catheters ≤ 8.7Fr and has an approximate working length of 720mm. It is designed to provide flexible catheter positioning in the cardiac anatomy. The handle is equipped with a bi-directional rotating knob to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. There are two different models: The Symmetric Steerable Sheath has a tip that can be deflected into two distal curve geometries of equal symmetry, with reduced stroke in one direction; and the Asymmetric Steerable Sheath - one distal curve equal to the symmetric curve geometry above and a longer 'reach' curve geometry on the opposite curve to facilitate broader steering angles. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side-port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The steerable sheath features distal perfusion holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. The Creganna-Tactx Steerable Sheath is packaged as a set with the following accessories that are compatible with the dimensions of the steerable sheath: a polymer curved dilator (approximately 8.7 Fr), a 0.032" PTFE coated stainless steel J-tipped quidewire, and a guidewire J-straightener (introducer). The Set components are packaged together, provided sterile, and is intended for single use only. The Creganna-Tactx Steerable Sheath Set assembly is comprised of materials that are commonly used in medical device applications.
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