# K030999: Eptfe Vascular Prosthesis; Sealptfe

- Pathway: 510(k) (Special)
- Applicant: Vascutek, Ltd.
- Decided: Apr 9, 2003 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.
3 later devices descend from it; 1 cites 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
- K130215: Gore Acuseal Vascular Graft (2013), 2 descendants of its own
- K231505: GORE® ACUSEAL Vascular Graft (2023), 1 descendant of its own
- K233551: GORE® ACUSEAL Vascular Graft (2023), 0 descendants of its own

## Indications for use
The ePTFE vascular prosthesis is intended for: CREATION OF SUBCUTANEOUS ARTERIOVENOUS CONDUITS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

Source page: https://510kreport.com/device/K030999
Methodology: https://510kreport.com/methodology