Carotid Stent System


Product Overview

Carotid Stent System
Protege RX - SECX-6-20-135


Device Description

A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep dry

  • Device Sizes

  • Length: 20 Millimeter
  • Working Length,135,Centimeter;Compatible Guidewire,.014,Inch;Lumen Diameter,4.5 to 5.5,Millimeter;
  • Catheter Gauge: 6 French
    • Length: 20 Millimeter
    • Working Length,135,Centimeter;Compatible Guidewire,.014,Inch;Lumen Diameter,4.5 to 5.5,Millimeter;
    • Catheter Gauge: 6 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NIM

    Device Name: Stent, Carotid

    Device Class: 3

    Physical State: N/A

    Definition: Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00821684038499

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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