The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To Smart Control Nitinol Stent Transhepatic Biliary System.
| Device ID | K042969 |
| 510k Number | K042969 |
| Device Name: | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-28 |
| Decision Date | 2004-11-08 |
| Summary: | summary |