Self-Expanding Peripheral Stent System

Self
EverFlex - PRB35-07-040-080

A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.

• Catheter Gauge: 6 French
• Length: 40 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 7 Millimeter
• Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5 to 6.5,Millimeter;

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NIP

Device Name: Stent, Superficial Femoral Artery

Device Class: 3

Physical State: N/A

Definition: Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery 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: 00821684033838

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