The following data is part of a premarket notification filed by Cordis, A Johnson & Johnson Co. with the FDA for Cordis Palmaz Genesis Transhepatic Biliary Stent.
| Device ID | K012090 |
| 510k Number | K012090 |
| Device Name: | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS, A JOHNSON & JOHNSON CO. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Charles J Ryan |
| Correspondent | Charles J Ryan CORDIS, A JOHNSON & JOHNSON CO. 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 | 2001-07-05 |
| Decision Date | 2001-08-01 |
| Summary: | summary |