The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Nitinol Stent And Delivery System.
| Device ID | K980823 |
| 510k Number | K980823 |
| Device Name: | CORDIS NITINOL STENT AND DELIVERY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 40 TECHNOLOGY DR. P.O. BOX 4917 Warren, NJ 07059 |
| Contact | Joan Martin |
| Correspondent | Joan Martin CORDIS CORP. 40 TECHNOLOGY DR. P.O. BOX 4917 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 | 1998-03-03 |
| Decision Date | 1998-12-18 |
| Summary: | summary |