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510(k) Data Aggregation

    K Number
    K221280
    Device Name
    Vesseal
    Manufacturer
    Lydus Medical Ltd.
    Date Cleared
    2022-12-09

    (220 days)

    Product Code
    GAW, GAR
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lydus Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts.
    Device Description
    The Vesseal is a hand-held device, enabling simultaneous deployment of 8 double-armed 9-0 to 7-0 nylon sutures (USP certified). The sutures are delivered from the inside out, around the circumference of two ends of blood vessels (ranging in size from 2mm to 4mm) to assist in the creation of a microvascular anastomosis. The Vesseal is comprised of two main mechanisms: 1. The needle insertion mechanism contains two rod protrusions, intended for locating the blood vessel, opening, mounting, and positioning them relative to the stopper mechanism. Each rod stores, 8 curved needles that allow the transition of the double-armed nylon sutures during deployment. 2. The handle deployment mechanism features right and left switches to deploy the needles on the respective rod side, and the gear to rotate the rod and enable access to its entire perimeter.
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