- Physicians Office Resource

Carotid Stent System
Protege RX - SECX-9-20-135

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,7.5 to 8.5,Millimeter;

Catheter Gauge: 6 French

Length: 20 Millimeter
Working Length,135,Centimeter;Compatible Guidewire,.014,Inch;Lumen Diameter,7.5 to 8.5,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: 00821684038529

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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