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510(k) Data Aggregation

    K Number
    K240119
    Device Name
    VasQ
    Date Cleared
    2024-02-16

    (31 days)

    Product Code
    Regulation Number
    870.4600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laminate Medical Technologies Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery.
    Device Description
    VasQ is designed for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery. The design of the device is intended to promote outward remodeling of the AVF vein and ultimate usability of the fistula by aiding in the maintenance of optimal hemodynamic flow profile and relieving excessive mechanical stress at the anastomotic connection. Implantation of the device does not interfere with the standard surgical techniques required to create the AVF (i.e. dissection, mobilization and suturing the anastomosis).
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    K Number
    DEN220026
    Device Name
    VasQ
    Date Cleared
    2023-09-26

    (515 days)

    Product Code
    Regulation Number
    870.4600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laminate Medical Technologies Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery.
    Device Description
    VasQ is a nitinol implant that is used to provide external support for arteriovenous fistulas (AVF) created by means of vascular surgery. VasO is comprised of a braid and a brace that are welded together (Figure 1). The braid is woven nitinol mesh that provides structural support to the segment of the vein that must be mobilized from its natural supporting tissue to allow surgical anastomosis to the artery. The brace is a laser cut nitinol structure intended to maintain geometric properties at the juxta-anastomosis region of the AVF.
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