# K091491: Hero Vascular Access Device

- Pathway: 510(k) (Special)
- Applicant: Hemosphere, Inc.
- Decided: Jul 31, 2009 after 72 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: 5 generations back to K791810 (1979). 17 ancestors in all.
6 later devices descend from it; 3 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)
- K071778: Hero Vascular Access Device, Graftcath, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K203724: HeRO Graft, HeRO Adapter (2021), 1 descendant of its own

## Indications for use
The HeROTM Vascular Access Device 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 K/DOQI guidelines1 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 or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography. * Are receiving inadequate dialysis clearance (i.e., low KtW) via catheters. K/DOQI guidelines recommend a minimum Kt/V of 1.4.2

Source page: https://510kreport.com/device/K091491
Methodology: https://510kreport.com/methodology