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510(k) Data Aggregation

    K Number
    K160529
    Device Name
    Pledgeted COR-SUTURE QUICK LOAD
    Manufacturer
    LSI SOULTIONS
    Date Cleared
    2016-09-15

    (203 days)

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

    LSI SOULTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pledgeted COR-SUTURE™ QUICK LOAD® is intended for use in the approximation of soft tissue and prosthetic material.
    Device Description
    Each LSI SOLUTIONS® Pledgeted COR-SUTURE™ QUICK LOAD® sterile surgical suture is held in a customized tray, with suture release feature designed to enable the rapid, easy and reliable loading of suture into compatible LSI SOLUTIONS® suturing devices. Pledgeted COR-SUTURE™ QUICK LOAD® suture is available as a non-absorbable monofilament polypropylene and PTFE coated, braided, polyester surgical suture with attached PTFE pledget. A short length of modified surgical stainless steel tubing, called a "ferrule", is attached to each end of the suture. The Pledgeted COR-SUTURE™ QUICK LOAD® suture also includes a detachable clear suture tube to keep the suture from tangling. Pledgeted COR-SUTURE™ QUICK LOAD® surgical suture is packaged for single patient use. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper. The polyester suture is offered undyed, or dyed green with the FDA approved colorant D&C Green No. 6. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The Pledgeted COR-SUTURE™ QUICK LOAD® surgical suture is MR safe.
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