# K213845: HeRO Graft

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 15, 2022 after 249 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: 11 generations back to K791810 (1979). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203724: HeRO Graft, HeRO Adapter, Merit Medical Systems, Inc. (2021) Summary page 4.

## 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 Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

Source page: https://510kreport.com/device/K213845
Methodology: https://510kreport.com/methodology