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510(k) Data Aggregation

    K Number
    K222603
    Device Name
    6F Wallaby Long Sheath
    Manufacturer
    Wallaby Medical Inc
    Date Cleared
    2023-03-02

    (185 days)

    Product Code
    DQY, QJP
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wallaby Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
    Device Description
    The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy. The 6F Wallaby Long Sheath is a non-active, surgically invasive device intended for short term use within the vasculature.
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