The following data is part of a premarket notification filed by Cordis Europa N.v. with the FDA for Cordis Palmaz Blue Transhepatic Biliary Stent On Slalom .018 Delivery System.
| Device ID | K040413 |
| 510k Number | K040413 |
| Device Name: | CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS EUROPA N.V. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk CORDIS EUROPA N.V. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-18 |
| Decision Date | 2004-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032036358 | K040413 | 000 |
| 20705032035986 | K040413 | 000 |
| 20705032035955 | K040413 | 000 |
| 20705032035948 | K040413 | 000 |
| 20705032035894 | K040413 | 000 |
| 20705032035887 | K040413 | 000 |
| 20705032035832 | K040413 | 000 |
| 20705032035825 | K040413 | 000 |
| 20705032035795 | K040413 | 000 |
| 20705032035788 | K040413 | 000 |
| 20705032035757 | K040413 | 000 |
| 20705032035740 | K040413 | 000 |
| 20705032035719 | K040413 | 000 |
| 20705032035702 | K040413 | 000 |
| 20705032035672 | K040413 | 000 |
| 20705032035993 | K040413 | 000 |
| 20705032036020 | K040413 | 000 |
| 20705032036341 | K040413 | 000 |
| 20705032036310 | K040413 | 000 |
| 20705032036303 | K040413 | 000 |
| 20705032036273 | K040413 | 000 |
| 20705032036266 | K040413 | 000 |
| 20705032036235 | K040413 | 000 |
| 20705032036228 | K040413 | 000 |
| 20705032036198 | K040413 | 000 |
| 20705032036181 | K040413 | 000 |
| 20705032036150 | K040413 | 000 |
| 20705032036143 | K040413 | 000 |
| 20705032036099 | K040413 | 000 |
| 20705032036082 | K040413 | 000 |
| 20705032036037 | K040413 | 000 |
| 20705032035665 | K040413 | 000 |