The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Primus Gps Biliary Stent System.
| Device ID | K061566 |
| 510k Number | K061566 |
| Device Name: | PRIMUS GPS BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EV3 INC 9600 54TH AVENUE NORTH Plymouth, MN 55442 -2920 |
| Contact | Melissa Sommerfeld |
| Correspondent | Melissa Sommerfeld EV3 INC 9600 54TH AVENUE NORTH Plymouth, MN 55442 -2920 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-06 |
| Decision Date | 2006-08-31 |
| Summary: | summary |