Data / Medical devices / Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (DYF): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF, Class 2, 21 CFR 870.3450). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on May 14, 2001, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DYF
- Device class
- 2
- Regulation
- 870.3450
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Prosthesis, Vascular Graft, Of Less Then 6mm 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 |
|---|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | May 14, 2001 | 0 | 0 | 0 | api.fda.gov |
| Atrium Medical Corporation | Merrimack, NH, United States | Manufacturer | 1 | October 1, 1999 | 0 | 2 | 0 | api.fda.gov |
| Maquet Cardiovascular LLC | Wayne, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peca Labs, Inc. | Pittsburgh, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W. L. Gore & Associates, Inc | Flagstaff, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 14, 2001. 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.