Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
FDA 510(k) K162803 · Vascutek, Ltd.
510(k) numberK162803
Submission
- Device name
- Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
- Applicant
- Vascutek, Ltd.
Inchinnan, GB - Received
- October 5, 2016
- Decision date
- July 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252445 | Fusion Bioline Vascular GraftDSY · Traditional | Maquet Cardiovascular, LLC | 04/27/2026SE |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)DSY · Traditional | Vascular Flow Technologies Limited | 10/20/2025SE |
| K241550 | Gelweave Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 02/27/2025SE |
| K241070 | Gelsoft Plus Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 11/15/2024SE |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional | Atrium Medical Corporation | 03/28/2024SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 03/01/2024SE |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsDSY · Traditional | Peca Labs, Inc. | 01/17/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | W. L. Gore & Associates, Inc. | 06/23/2023SE |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241550 | Gelweave Vascular ProsthesesDSY · Traditional | 02/27/2025SE |
| K241070 | Gelsoft Plus Vascular ProsthesesDSY · Traditional | 11/15/2024SE |
| K202703 | Vascutek Gelsoft Plus ERS Vascular GraftDSY · Traditional | 04/06/2021SE |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ · Traditional | 07/08/2020SE |
| K162794 | Gelweave Vascular GraftsDSY · Traditional | 06/30/2017SE |
| K093817 | Gelweave Branched Vascular Grafts with Radiopaque MarkersDSY · Special | 01/07/2010SE |
| K092863 | Maxiflo, TaperfloDSY · Special | 10/08/2009SE |
| K091778 | Vascutek Cobrahood Eptfe Vascular GraftsDSY · Traditional | 08/31/2009SE |
| K090987 | Vascutek Branched GelweaveDSY · Traditional | 06/19/2009SE |
| K081560 | Vascutek Cannula Graft, Model CGS2008SDWF · Traditional | 02/10/2009SE |
Questions and answers
When was Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts cleared by the FDA?
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (K162803) received a 510(k) decision of Substantially Equivalent on July 14, 2017, 282 days after the submission was received.
What is the product code of K162803?
The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.