Data / Medical devices / Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (DSY): 13 FDA-registered makers in 3 countries
13 establishments in 3 countries are registered with the FDA to make Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY, Class 2, 21 CFR 870.3450). 12 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 188 510(k) clearances under this code, the latest on April 27, 2026, and lists 21 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DSY
- Device class
- 2
- Regulation
- 870.3450
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| United Kingdom | 2 |
| France | 1 |
Makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vascutek Ltd. | Inchinnan Renfrewshire, United Kingdom | Manufacturer | 14 | February 27, 2025 | 0 | 3 | 0 | api.fda.gov |
| W. L. Gore & Associates, Inc | Flagstaff, AZ, United States | Manufacturer | 12 | March 1, 2024 | 0 | 2 | 0 | api.fda.gov |
| Intervascular SAS | LA CIOTAT Bouches-du-Rhone, France | Manufacturer | 7 | February 2, 2011 | 0 | 3 | 0 | api.fda.gov |
| Peca Labs, Inc. | Pittsburgh, PA, United States | Manufacturer, Manufacturer for export | 5 | January 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Atrium Medical Corporation | Merrimack, NH, United States | Manufacturer | 4 | March 28, 2024 | 0 | 3 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | September 20, 2005 | 0 | 1 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 4 | August 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Genesee Biomedical, Inc. | Denver, CO, United States | Manufacturer, Specification developer | 1 | March 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 1 | February 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 1 | February 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Maquet Cardiovascular LLC | Wayne, NJ, United States | Manufacturer | 1 | April 27, 2026 | 0 | 6 | 0 | api.fda.gov |
| Vascular Flow Technologies Ltd | Dundee Dundee City, United Kingdom | Specification developer | 1 | October 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.