The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Zilver 518tm Biliary Stent; Zilver 635tm Biliary Stent.
| Device ID | K163169 |
| 510k Number | K163169 |
| Device Name: | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Contact | Charlene Ryan |
| Correspondent | Charlene Ryan 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 | 2016-11-14 |
| Decision Date | 2017-02-07 |
| Summary: | summary |