HeRO® Graft Adapter - The HeRO (Hemodialysis Reliable Outflow) Graft is - Cryolife, Inc.

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.

Want to know more about this Product? Request more information now!


More Product Details

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

Product Characteristics

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 Details

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CRYOLIFE, INC." Characteristics
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