The following data is part of a premarket notification filed by Cordis Corp. with the FDA for S.m.a.r.t. Nitinol Stent Transhepatic Biliary System.
| Device ID | K994068 |
| 510k Number | K994068 |
| Device Name: | S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Elena Jugo |
| Correspondent | Elena Jugo CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-02 |
| Decision Date | 1999-12-23 |
| Summary: | summary |