# K051312: Swirlgraft Bypass and Vascular Access Grafts

- Pathway: 510(k) (Traditional)
- Applicant: Veryan Medical Limited
- Decided: Nov 4, 2005 after 169 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 K992832 (1999). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992832: Sulzer Vascutek Eptfe Vascular Prosthesis, Sulzermedica (1999) Summary page 1.

## Most influential descendants
- K083169: Eptfe Slftm Spiral Vascular Graft (2009), 4 descendants of its own
- K142062: Spiral Flow Peripheral Vascular Graft (2014), 1 descendant of its own
- K094044: Spiral Laminar Flow Vascular Arteriovenous Graft (2010), 1 descendant of its own
- K252277: Spiral Laminar Flow™ Vascular Arteriovenous Graft  (AV0645) (2025), 0 descendants of its own
- K150389: Spiral Flow Peripheral Vascular Graft (2015), 0 descendants of its own

## Indications for use
The SwirlGraft Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels. The SwirlGraft Vascular Access Graft is intended for use as a subcutaneous arterio-venous conduit for vascular access.

Source page: https://510kreport.com/device/K051312
Methodology: https://510kreport.com/methodology