Duns Number:119253177
Device Description: The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm access solution for access-ch The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm access solution for access-challenged and catheter-dependentpatients. 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. Itconsists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker bandat 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.
Catalog Number
HERO 1004
Brand Name
HeRO® Graft Adapter
Version/Model Number
HERO 1004
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2016
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSY
Product Code Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Public Device Record Key
6421bad5-6ae4-44a9-bac3-ae1e06c716e3
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
November 23, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |
3 | A medical device with high risk that requires premarket approval | 8 |
U | Unclassified | 2 |