The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Zilver 635 Biliary Stent.
| Device ID | K163018 |
| 510k Number | K163018 |
| Device Name: | Zilver 635 Biliary Stent |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick, IE |
| Contact | Nora O'connor |
| Correspondent | Nora O'connor Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick, IE |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2016-12-23 |
| Summary: | summary |