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

Duns Number:119253177

Device Description: The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-c 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 ComponentThe HeRO Graft Arterial Graft Component has a 6mm ID, 7.4mm OD, and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the titanium connector. The titanium connector attaches the Arterial Graft Component to the HeRO Graft Venous Outflow Component. The HeRO Graft Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.

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More Product Details

Catalog Number

HERO 1002

Brand Name

HeRO® Graft Arterial Graft Component

Version/Model Number

HERO 1002

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

33b23bc3-aac4-498c-9a57-8533868523f1

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 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