The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Precise Rx Nitinol Stent Transhepatic Biliary System.
| Device ID | K041796 |
| 510k Number | K041796 |
| Device Name: | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORPORATION 14201 N.W. 60TH AVENUE Miami Lakes, FL 33014 |
| Contact | Elena S Jugo |
| Correspondent | Elena S Jugo CORDIS CORPORATION 14201 N.W. 60TH AVENUE 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 | 2004-07-02 |
| Decision Date | 2004-08-03 |
| Summary: | summary |