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510(k) Data Aggregation

    K Number
    K061626
    Device Name
    VASORING* VRC VASCULAR RING CONNECTOR
    Date Cleared
    2006-10-05

    (115 days)

    Product Code
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNWEI TECH CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VASORING* VRC Vascular Ring Connector is indicated for use as a connector for attaching a vascular graft to native tissue where conditions preclude a conventional end-to-end sutured anastomosis.
    Device Description
    The vascular ring connector is made of biocompatible titanium alloy. Placed in the vascular prosthesis to form a Graft-Connector Unit, it can be used as an intraluminal graft. The braided ligature tape (Ethicon® Nylon Tape) is for tying the ring connector from outside of the blood vessel to provide sutureless anastomosis that is time-saving. There are two grooves on the outer surface of the connector: the narrow groove is for suture fixation between the connector and the vascular prosthesis; and the wider groove is for ligature fixation between the connector and the blood vessel. The titanium alloy allows the ring connector to be of thin-wall design which gives larger inner diameter while maintaining adequate mechanical strength at the anastomotic sites.
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