The following data is part of a premarket notification filed by Veryan Medical Limited with the FDA for Swirlgraft Vascular Access Graft.
| Device ID | K060741 |
| 510k Number | K060741 |
| Device Name: | SWIRLGRAFT VASCULAR ACCESS GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VERYAN MEDICAL LIMITED 1327 BLUEGRASS WAY Gambrills, MD 21054 |
| Contact | Semith Oktay |
| Correspondent | Semith Oktay VERYAN MEDICAL LIMITED 1327 BLUEGRASS WAY Gambrills, MD 21054 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-04-05 |