FLAIR® Endovascular Stent Graft 9 mm x 50 mm (80 cm delivery catheter)(flared)
Flair® Endovascular Stent Graft - FAF09050
Device Description
A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary 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 in addition be intended for optional venous implantation. It does not include anticoagulant or antiproliferative pharmaceuticals. It is a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft) available in various sizes. It is percutaneously inserted with a disposable delivery device which may be included with the stent-graft.
Environmental Conditions
- Protect the packaged product from direct sunlight
- Keep dry
- Keep away from sunlight
- Store in a cool (room temperature), dry place
Device Sizes
- Implant Length,50 Millimeter
- Implant Diameter,9 Millimeter
- Catheter Length,80 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 04049519008875
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: 14049519008872
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04049519008875
Package Quantity: 1
Package Discontinue Date: 5/10/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Other