# K955230: Vascutek Gelsoft Plus Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Feb 9, 1996 after 87 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K162803: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (2017), 1 descendant of its own
- K241070: Gelsoft™ Plus Vascular Prostheses (2024), 0 descendants of its own

## Recalls of this device
- Jul 8, 2021 · Class II · Z-2542-2021: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Source page: https://510kreport.com/device/K955230
Methodology: https://510kreport.com/methodology