The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To Smart Control Nitinol Stent Transhepatic Biliary System.
Device ID | K042969 |
510k Number | K042969 |
Device Name: | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
Contact | Donna Marshall |
Correspondent | Donna Marshall 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 | 2004-10-28 |
Decision Date | 2004-11-08 |
Summary: | summary |