RX ACCULINK Carotid Stent System 7.0 mm x 30 mm x 132 cm Rapid-Exchange


Product Overview

RX ACCULINK Carotid Stent System 7.0 mm x 30 mm x 132 cm Rapid
Acculink - 1011339-30


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

  • Handling Environment Temperature - Degrees Celsius
    • 55.00
    • -20.00
  • Special Storage Condition, Specify
    • Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
  • Storage Environment Temperature - Degrees Celsius
    • 55.00
    • -20.00

  • Device Sizes

    No Data Available


    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: 08717648076251

    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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