# K071778: Hero Vascular Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Graftcath, Inc.
- Decided: Jan 30, 2008 after 212 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: 4 generations back to K791810 (1979). 16 ancestors in all.
7 later devices descend from it; 4 cite 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)
- K052964: Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven, Boston Scientific Corp (2006) Summary page 1.
- K032900: Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts, Edwards Lifesciences, LLC (2003) Summary page 1.
- (no number) Bard Access Systems Hickman Chronic Dialysis Catheter: named in the summary without a submission number

## Most influential descendants
- K091491: Hero Vascular Access Device (2009), 6 descendants of its own
- K120006: Hero Graft (2012), 5 descendants of its own
- K121532: Hero Graft (2012), 4 descendants of its own
- K124039: Hero Graft (2013), 3 descendants of its own
- K172637: HeRO Graft (2017), 2 descendants of its own

## Indications for use
The HeRO vascular access device 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 K/DOQI 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. 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 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 Kt/V) via catheters. K/DOQI guidelines recommend a minimum Kt/V of 1.4.

Source page: https://510kreport.com/device/K071778
Methodology: https://510kreport.com/methodology