The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Smart Control Nitinol Stent Transhepatic Biliary System.
| Device ID | K021898 |
| 510k Number | K021898 |
| Device Name: | SMART CONTROL 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 | Sam Mirza |
| Correspondent | Sam Mirza 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 | 2002-06-10 |
| Decision Date | 2002-08-14 |
| Summary: | summary |