The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Evolution Duodenal Stent System, Model Evo-22-27-6-d, Evo-22-27-9-d, Evp-22-27-12-d.
| Device ID | K101530 |
| 510k Number | K101530 |
| Device Name: | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D |
| Classification | Stent, Metallic, Expandable, Duodenal |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE Ei |
| Contact | Jacinta Kilmartin |
| Correspondent | Jacinta Kilmartin COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE Ei |
| Product Code | MUM |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-03 |
| Decision Date | 2011-03-29 |
| Summary: | summary |