# K124039: Hero Graft

- Pathway: 510(k) (Traditional)
- Applicant: Hemoshpere, Inc., A Cryolife Company
- Decided: Mar 7, 2013 after 69 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K791810 (1979). 20 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071778: Hero Vascular Access Device, Graftcath, Inc. (2008) Summary page 1.
- K091491: Hero Vascular Access Device, Hemosphere, Inc. (2009) Summary page 2.
- K120006: Hero Graft, Hemosphere, Inc. (2012) Summary page 2.
- K121532: Hero Graft, Hemosphere, Inc. (2012) Summary page 2.

## Most influential descendants
- K172637: HeRO Graft (2017), 2 descendants of its own
- K203724: HeRO Graft, HeRO Adapter (2021), 1 descendant of its own
- K213845: HeRO Graft (2022), 0 descendants of its own

## Indications for use
The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines' as patients who: * Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts). * Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography. * Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage). * Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography. * Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography. * Are receiving inadequate dialysis clearance (i.e., low KtNV) via catheters. KOOQI guidelines recommend a minimum KtNV of 1. .~2

Source page: https://510kreport.com/device/K124039
Methodology: https://510kreport.com/methodology