# K200955: Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Jul 8, 2020 after 90 days
- Product code: DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931386 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963611: Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch, Vascutek, Ltd. (1996) Summary page 5.

## Indications for use
Vascutek Cardiovascular Fabric is indicated for vascular or cardiovascular repair whenever knitted polyester fabrics are normally indicated. Due to its particularly high strength, Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for patch closure after endarterectomy, particularly of the carotid arteries.

Source page: https://510kreport.com/device/K200955
Methodology: https://510kreport.com/methodology