# K032900: Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 4, 2003 after 78 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: 1 generation back to K933590 (1994). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933590: Baxter Reinforced Expanded Ptfe Vascular Graft, Baxter Healthcare Corp (1994) Summary page 2.
- K944844: Baxter Reinforced Expanded Ptfe Stepped Vascular Graft, Baxter Healthcare Corp (1995) Summary page 2.
- K944858: Baxter Eptfe Externally Supported Vascular Grafts, Baxter Edwards (1995) Summary page 2.

## Most influential descendants
- 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
- K124039: Hero Graft (2013), 3 descendants of its own

## Indications for use
The Edwards Lifespan ePTFE Vascular Grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.

Source page: https://510kreport.com/device/K032900
Methodology: https://510kreport.com/methodology