# K041528: Modification to Eptfe Graft

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Sep 14, 2004 after 98 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K081560: Vascutek Cannula Graft, Model CGS2008S (2009), 1 descendant of its own
- K203057: Quantum Perfusion Arterial Cannula Graft (2021), 0 descendants of its own
- K091778: Vascutek Cobrahood Eptfe Vascular Grafts (2009), 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/K041528
Methodology: https://510kreport.com/methodology