Advanta VXT Vascular Graft, Flixene Vascular Graft
FDA 510(k) K231972 · Atrium Medical Corporation
510(k) numberK231972
Submission
- Device name
- Advanta VXT Vascular Graft, Flixene Vascular Graft
- Applicant
- Atrium Medical Corporation
Merrimack, NH, US - Received
- July 3, 2023
- Decision date
- March 28, 2024
- 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 |
| 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 |
|---|---|---|
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | 09/03/2021SE |
| K151386 | C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicFTL · Traditional | 10/22/2015SE |
| K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugFTL · Traditional | 08/27/2015SE |
| K130142 | Flixene Ifg Vascular GraftDSY · Traditional | 03/15/2013SE |
| K130131 | Edrain Chest Drainage SystemBTA · Traditional | 02/28/2013SE |
| K122138 | Atrium Flixene Ifg Vascular GraftDSY · Special | 08/17/2012SE |
| K121070 | C-Qur RPM MeshFTL · Special | 04/26/2012SE |
| K113112 | Clearway RX NB CatheterDQY · Special | 11/17/2011SE |
| K110110 | Atrium Centrilfx MeshFTL · Special | 02/15/2011SE |
| K102596 | Atrium Graduated Wall Flixene Ax-Bifem GraftDSY · Special | 10/05/2010SE |
Questions and answers
When was Advanta VXT Vascular Graft, Flixene Vascular Graft cleared by the FDA?
Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972) received a 510(k) decision of Substantially Equivalent on March 28, 2024, 269 days after the submission was received.
What is the product code of K231972?
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.