# K060142: Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers

- Pathway: 510(k) (Special)
- Applicant: Vascutek, Ltd.
- Decided: Feb 7, 2006 after 19 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
- K162794: Gelweave Vascular Grafts (2017), 1 descendant of its own
- K241550: Gelweave™ Vascular Prostheses (2025), 0 descendants of its own
- 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/K060142
Methodology: https://510kreport.com/methodology