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510(k) Data Aggregation
K Number
K061626Device Name
VASORING* VRC VASCULAR RING CONNECTOR
Manufacturer
Date Cleared
2006-10-05
(115 days)
Product Code
Regulation Number
870.3450Why 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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