The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Evolution Esophageal Stent Fully Covered, Models Evo-fc-18-23-8-e, Evo-fc-18-23-10-e, Evo-fc-18-23-12-e.
| Device ID | K093619 |
| 510k Number | K093619 |
| Device Name: | EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E |
| Classification | Prosthesis, Esophageal |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Contact | Jacinta Kilmartin |
| Correspondent | Jacinta Kilmartin COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2010-06-17 |
| Summary: | summary |