HeRO® Graft Adapter
The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It…
The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm 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. The HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of a proprietary Venous Outflow Component and only one of the following options: • The Arterial Graft Component (not included) • The Adapter (a separate commercially available 6mm ID vascular graft is not included with the Adapter) The Venous Outflow Component (not included) has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip. The Adapter connects a 6mm ID vascular graft (not included) to the Venous Outflow Component. The Adapter (titanium) has a tapered ID (6mm to 5mm) to provide a smooth transition from a 6mm ID vascular graft to the 5mm ID Venous Outflow Component. A disposable Graft Expander is provided to aid in connecting a 6mm ID vascular graft to the Adapter. See Instructions for Use for further details regarding the grafts permitted for use with the Adapter.
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Artivion, Inc., United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-11-23 |
| Record revised | 2024-02-19 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry and Out of Direct Sunlight; Storage environment temperature 15 to 30 °C |
| Distribution end date | 2016-06-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HERO 1004 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| BioFlo | Navilyst Medical, Inc. | 45 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.