Data / Medical devices / Prosthesis, Vascular Graft, Of 6mm And Greater Diameter / United States
FDA-registered makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY). 9 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Product code
- DSY
- Country
- United States
Makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| W. L. Gore & Associates, Inc | Flagstaff, AZ, United States | Manufacturer | 12 | March 1, 2024 | 0 | 2 | 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 |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.