AAA GUIDE DEVICE 28 EIFU

AAA GUIDE DEVICE 28 EIFU
Heli-FX™ EndoAnchor™ System - HG-16-62-28

A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

• Outer Diameter: 5.3 Millimeter
• Length: 28.0 Millimeter
• Length: 62.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OTD

Device Name: Endovascular Suturing System

Device Class: 2

Physical State: The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.

Definition: Provides fixation and sealing between and endovascular graft and the native artery.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses a metallic implant, delivered through a catheter-based system, to affix the material of an endovascular graft to native vessel

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: The implant is to be placed at the proximal end of an aortic aneurysm.

Regulation Number: 870.3460

Third Party Flag: N

Medical Specialty: CV

Device Id: 00763000025267

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