FLAIR® Endovascular Stent Graft 9 mm x 40 mm (80 cm delivery catheter)(straight)

FLAIR® Endovascular Stent Graft 9 mm x 40 mm (80 cm delivery catheter)(straight)
Flair® Endovascular Stent Graft - FAS09040

A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is a metallic mesh-like structure with a synthetic polymer tube (endovascular graft); it does not include pharmaceuticals.

• Implant Length,40 Millimeter
• Implant Diameter,9 Millimeter
• Catheter Length,80 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PFV

Device Name: System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Device Class: 3

Physical State: The endovascular stent-graft is a metal scaffold covered with fabric material. The stent-graft is placed via a delivery catheter into the arteriovenous dialysis access circuit to maintain or re-establish vessel patency for hemodialysis. The endovascular stent-grafts are available in various diameters and lengths.

Definition: An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Generally, a Peripheral Transluminal Angioplasty (PTA) catheter is used initially to open up the occlusion and allow for passage of the endovascular graft delivery system to pass through. The endovascular graft is then deployed at the site of the occlusion with the structural stent component propping open the vessel. The covered stent assists in maintaining vessel patency post-procedure.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Stenotic lesions or thrombotic occlusions in the arteriovenous dialysis access circuit, including the venous anastomosis.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 04049519009025

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

Device Id: 14049519009022

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04049519009025

Package Quantity: 1

Package Discontinue Date: 5/10/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Other