The following data is part of a premarket notification filed by Veryan Medical Limited with the FDA for Swirlgraft Bypass And Vascular Access Grafts.
| Device ID | K051312 |
| 510k Number | K051312 |
| Device Name: | SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VERYAN MEDICAL LIMITED 1327 BLUEGRASS WAY Gambrills, MD 21054 |
| Contact | Judith Danielson |
| Correspondent | Judith Danielson VERYAN MEDICAL LIMITED 1327 BLUEGRASS WAY Gambrills, MD 21054 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-19 |
| Decision Date | 2005-11-04 |
| Summary: | summary |