The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Biliary Stent.
| Device ID | K955728 |
| 510k Number | K955728 |
| Device Name: | CORDIS BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marlene W Valenti |
| Correspondent | Marlene W Valenti CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-05-08 |
| Summary: | summary |