The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Medium Palmaz Transhepatic Biliary Stent & Delivery.
| Device ID | K000564 |
| 510k Number | K000564 |
| Device Name: | CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk 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 | 2000-02-22 |
| Decision Date | 2000-03-23 |