The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Palmaz Blue .014 Transhepatic Biliary Stent System-model Pb1550,bas,bax,pb1560,bas,bax,pb1850,bas,baxpb1860bas,bax.
| Device ID | K060877 |
| 510k Number | K060877 |
| Device Name: | PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX |
| 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 | 2006-03-31 |
| Decision Date | 2006-04-27 |
| Summary: | summary |