AFX Endovascular AAA System

Basic Information

• Brand Name: AFX Endovascular AAA System
• Primary DI: 00818009011398
• Version / Model: I16-16/C55 SA
• Company Name: ENDOLOGIX, INC.
• Labeler DUNS: 858560477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 8
• Public Version Date: 2023-01-10
• Public Version Status: Update
• Public Device Record Key: 5cdb92c7-8919-48b0-ba8e-5228e8d24026

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46777	Abdominal aorta endovascular stent-graft	A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA); it does not contain anticoagulants or pharmaceuticals that prevent narrowing of the vessels. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is typically made of a metallic outer mesh structure with an inner polymer tube (endovascular graft) and is typically available in two designs: 1) a single tube for insertion into one iliac artery; or 2) a two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818009011398	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P040002	038
P040002	039
P040002	040
P040002	041
P040002	042
P040002	043
P040002	044
P040002	045
P040002	046
P040002	047
P040002	048
P040002	050
P040002	051
P040002	052
P040002	054
P040002	056

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			16 mm, Proximal Diameter
Device Size Text, specify			0 mm, Uncovered Extension Length
Device Size Text, specify			55 mm, Covered Extension Length
Device Size Text, specify			16 mm, Distal Diameter