The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Palmaz Corinthian Transhepatic Biliary Stent And Accessories.
| Device ID | K991028 |
| 510k Number | K991028 |
| Device Name: | CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 40 TECHNOLOGY DR. Warren, NJ 07059 |
| Contact | Charles J Ryan |
| Correspondent | Charles J Ryan CORDIS CORP. 40 TECHNOLOGY DR. Warren, NJ 07059 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-08-04 |
| Summary: | summary |