# K944858: Baxter Eptfe Externally Supported Vascular Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: Jan 5, 1995 after 94 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032900: Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts (2003), 9 descendants of its own
- K071778: Hero Vascular Access Device (2008), 7 descendants of its own
- 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

Source page: https://510kreport.com/device/K944858
Methodology: https://510kreport.com/methodology