# K034010: Gelsoft Plus Ers

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Feb 19, 2004 after 57 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K202703: Vascutek Gelsoft Plus ERS Vascular Graft (2021), 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.

## Indications for use
EXTRA-ANATOMICAL VASCULAR REPAIR PRIMARILY FOR AXILLO-FEMORAL/BIFEMORAL BYPASS AND FEMORO-POPLITEAL RECONSTRUCTION

Source page: https://510kreport.com/device/K034010
Methodology: https://510kreport.com/methodology