# K202703: Vascutek Gelsoft Plus ERS Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Apr 6, 2021 after 202 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
Longest line of descent: 1 generation back to K034010 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034010: Gelsoft Plus Ers, Vascutek, Ltd. (2004) Summary page 5.

## Indications for use
Indicated for extra anatomical vascular repair, primarily for axillo-femoral/bi-femoral bypass and femoro- popliteal reconstruction.

Source page: https://510kreport.com/device/K202703
Methodology: https://510kreport.com/methodology