# K043552: Vascutek Ptfe Supported Eptfe Vascular Prostheses

- Pathway: 510(k) (Special)
- Applicant: Vascutek, Ltd.
- Decided: Jan 5, 2005 after 9 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
CREATION OF SUBCUTANEOUS ARTERIOVENOUS CONDUITS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

Source page: https://510kreport.com/device/K043552
Methodology: https://510kreport.com/methodology