The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of two primary components: • A proprietary Venous Outflow Component • A proprietary Arterial Graft Component The HeRO Graft Accessory Components provides instruments and accessories (such as, peel away sheaths and dilators, stylet, disposable clamp, hemostasis plug and hemostatic Y-valve with stopcock) that may aid in the placement of the HeRO Graft.

The HeRO (Hemodialysis Reliable Outflow) Graft is a long
HeRO® Graft Accessory Component Kit - HERO 1003

An implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct arteriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included.

• 16 French Dilator, Outer Diameter: 16 French
• 10 French Stylet, Outer Diameter: 10 French
• 10 French Stylet, Length: 47 Centimeters
• 20 F Sheath Introducer & Dilator, Sheath Length: 5.8 Inches
• 20 F Sheath Introducer & Dilator, Sheath Inner Diameter: 20 French
• 20 F Sheath Introducer & Dilator, Dilator Length: 7.9 Inches
• 20 F Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
• 20 F Short Sheath Introducer & Dilator, Sheath Length: 3.13 Inches
• 20 F Short Sheath Introducer & Dilator, Sheath Diameter: 20 French
• 20 F Short Sheath Introducer & Dilator, Dilator Length: 4.75 Inches
• 20 F Short Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
• 12 French Dilator, Length: 7.9 Inches
• 12 French Dilator, Outer Diameter: 12 French
• 16 French Dilator, Length: 7.9 Inches

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MSD

Device Name: Catheter, Hemodialysis, Implanted

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

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: 876.5540

Third Party Flag: N

Medical Specialty: GU

Code: LJS

Device Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 880.5970

Third Party Flag: N

Medical Specialty: HO

Code: DSY

Device Name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3450

Third Party Flag: N

Medical Specialty: CV

Device Id: 00877234000089

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