The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Cotton-huibregtse Stent, Cotton-leung Biliary Stent, Cotton-leung Sof-flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing Catheter, Fusion Pushing Catheter, Stent Introducer Set, Fusion Oasis One Ac.
| Device ID | K172044 |
| 510k Number | K172044 |
| Device Name: | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing Catheter, Fusion Pushing Catheter, Stent Introducer Set, Fusion Oasis One Ac |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Cook Ireland Ltd O'Halloran Road, National Technology Park Limerick, IE |
| Contact | Laura Graham |
| Correspondent | Jane Kennedy Cook Ireland Ltd O'Halloran Road, National Technology Park Limerick, IE |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-06 |
| Decision Date | 2018-02-27 |
| Summary: | summary |