# K990503: Sulzer Vascutek Gelsoft Vascular Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Sulzermedica
- Decided: Dec 9, 1999 after 295 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. The FDA summary names its predicate without a number.
- (no number) Meadox Hemashield Vantage Graft: named in the summary without a submission number
- (no number) Meadox Hemashield Microvel Double Velour Knitted Graft: named in the summary without a submission number
- (no number) Impra ePTFE Graft: named in the summary without a submission number

## 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
- Oct 23, 2013 · Class II · Z-0336-2014: Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufa

## Indications for use
Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.

Source page: https://510kreport.com/device/K990503
Methodology: https://510kreport.com/methodology