Fusion Bioline Vascular Graft
FDA 510(k) K252445 · Maquet Cardiovascular, LLC
510(k) numberK252445
Submission
- Device name
- Fusion Bioline Vascular Graft
- Applicant
- Maquet Cardiovascular, LLC
Wayne, NJ, US - Received
- August 4, 2025
- Decision date
- April 27, 2026
- 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 |
|---|---|---|---|
| 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 |
| K213845 | HeRO GraftDSY · Traditional | Merit Medical Systems, Inc. | 08/15/2022SE |
More from Merit Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3…GEI · Traditional | 05/30/2025SE |
| K243918 | Vasoview Hemopro 3 Power SupplyGEI · Traditional | 02/26/2025SE |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…GEI · Traditional | 02/27/2024SE |
| K191930 | 7 mm Extended Length EndoscopeGCJ · Traditional | 04/15/2020SE |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…GEI · Traditional | 09/17/2019SE |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/19/2016SE |
| K153523 | FUSION Vascular GraftDSY · Traditional | 02/16/2016SE |
| K132743 | Harvesting CannulaGEI · Traditional | 12/03/2013SE |
| K131778 | Fusion Vascular Graft and Fusion Bioline Vascular GraftDSY · Traditional | 11/14/2013SE |
| K122612 | Hemashield Woven Double Velour Vascular Graft Model M00202175XXXXX; M00202166XXXXXMAL · Traditional | 09/10/2012SE |
Questions and answers
When was Fusion Bioline Vascular Graft cleared by the FDA?
Fusion Bioline Vascular Graft (K252445) received a 510(k) decision of Substantially Equivalent on April 27, 2026, 266 days after the submission was received.
What is the product code of K252445?
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.