# K040829: Gelweave Ante-Flo with Collar and Gelweave 4 Branch Plexus with Collar

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: May 20, 2004 after 50 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K090987: Vascutek Branched Gelweave (2009), 0 descendants of its own

## Indications for use
REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE THORACIC AORTA IN CASES OF ANEURYSM, DISSECTION OR COARCTATION.

Source page: https://510kreport.com/device/K040829
Methodology: https://510kreport.com/methodology