Gelweave Vascular Prostheses
FDA 510(k) K241550 · Vascutek, Ltd.
510(k) numberK241550
Submission
- Device name
- Gelweave Vascular Prostheses
- Applicant
- Vascutek, Ltd.
Inchinnan, GB - Received
- May 31, 2024
- Decision date
- February 27, 2025
- 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 |
| 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 |
| K213845 | HeRO GraftDSY · Traditional | Merit Medical Systems, Inc. | 08/15/2022SE |
More from Merit Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsDSY · Traditional | 07/14/2017SE |
| 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 Gelweave Vascular Prostheses cleared by the FDA?
Gelweave Vascular Prostheses (K241550) received a 510(k) decision of Substantially Equivalent on February 27, 2025, 272 days after the submission was received.
What is the product code of K241550?
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.