The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To Cordis Palmaz Genesis Transhepatic Biliary Stent On Slalom .018 Delivery System.
| Device ID | K021345 |
| 510k Number | K021345 |
| Device Name: | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM |
| 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 | 2002-04-29 |
| Decision Date | 2002-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032040140 | K021345 | 000 |
| 20705032038741 | K021345 | 000 |
| 20705032038611 | K021345 | 000 |
| 20705032038604 | K021345 | 000 |
| 20705032038352 | K021345 | 000 |
| 20705032037959 | K021345 | 000 |
| 20705032037942 | K021345 | 000 |
| 20705032037898 | K021345 | 000 |
| 20705032037881 | K021345 | 000 |
| 20705032037621 | K021345 | 000 |
| 20705032037461 | K021345 | 000 |
| 20705032037232 | K021345 | 000 |
| 20705032037225 | K021345 | 000 |
| 20705032037171 | K021345 | 000 |
| 20705032037164 | K021345 | 000 |
| 20705032036792 | K021345 | 000 |
| 20705032036570 | K021345 | 000 |
| 20705032038758 | K021345 | 000 |
| 20705032039199 | K021345 | 000 |
| 20705032039281 | K021345 | 000 |
| 20705032040133 | K021345 | 000 |
| 20705032040065 | K021345 | 000 |
| 20705032040058 | K021345 | 000 |
| 20705032039984 | K021345 | 000 |
| 20705032039977 | K021345 | 000 |
| 20705032039908 | K021345 | 000 |
| 20705032039892 | K021345 | 000 |
| 20705032039748 | K021345 | 000 |
| 20705032039731 | K021345 | 000 |
| 20705032039663 | K021345 | 000 |
| 20705032039656 | K021345 | 000 |
| 20705032039588 | K021345 | 000 |
| 20705032039571 | K021345 | 000 |
| 20705032039502 | K021345 | 000 |
| 20705032039496 | K021345 | 000 |
| 20705032039298 | K021345 | 000 |
| 20705032036563 | K021345 | 000 |