# K952293: Vascutek Gelweave Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Dec 19, 1995 after 217 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013022: Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis (2002), 2 descendants of its own
- K964665: Vascutek Gelweave Vascular Graft (Bifurcated Configuration) (1997), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K952293
Methodology: https://510kreport.com/methodology