The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Protege Gps Self-expanding Nitinol Stent And Delivery System.
| Device ID | K033314 |
| 510k Number | K033314 |
| Device Name: | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EV3 INC 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920 |
| Contact | Glen D Smythe |
| Correspondent | Glen D Smythe EV3 INC 4600 NATHAN LN. 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 | 2003-10-15 |
| Decision Date | 2003-11-21 |
| Summary: | summary |