# K093817: Gelweave Branched Vascular Grafts with Radiopaque Markers

- Pathway: 510(k) (Special)
- Applicant: Vascutek, Ltd.
- Decided: Jan 7, 2010 after 27 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K162794: Gelweave Vascular Grafts (2017), 1 descendant of its own
- K241550: Gelweave™ Vascular Prostheses (2025), 0 descendants of its own

## Indications for use
Gelweave™ branched vascular grafts: “Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation”. Gelweave™ branched vascular grafts, including Siena™ grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures”.

Source page: https://510kreport.com/device/K093817
Methodology: https://510kreport.com/methodology