The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Evolution Biliary Stent System.
| Device ID | K121430 |
| 510k Number | K121430 |
| Device Name: | EVOLUTION BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE 000 |
| Contact | Jacinta Kilmartin |
| Correspondent | Jacinta Kilmartin COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE 000 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2013-03-01 |
| Summary: | summary |