Product Overview

CP10Z55 Bare CP Stent
CP Stent™ - 614473


Device Description

A non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.


Environmental Conditions

  • Special Storage Condition, Specify
    • KEEP AWAY FROM SUNLIGHT
  • Storage Environment Temperature - Degrees Celsius
    • 45.00
    • 5.00

  • Device Sizes

  • Length : 55.000 MM
    • Length : 55.000 MM


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PNF

    Device Name: Aortic Stent

    Device Class: 3

    Physical State: The stent is metal and is offered in a range of diameters

    Definition: Coarctation of the Aorta

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: An expandable stent is placed in the aorta to keep the vessel open

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Aorta

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 04046955091171

    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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