Carotid Stent System

Carotid Stent System
Protege RX - SECX-8-60-135

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.

• Length: 60 Millimeter
• Catheter Gauge: 6 French
• Working Length,135,Centimeter;Compatible Guidewire,.014,Inch;Lumen Diameter,6.5 to 7.5,Millimeter;

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00821684038666

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