The following data is part of a premarket notification filed by Ev3 Corporation with the FDA for Nitrex Nitinol Guidewire.
| Device ID | K031864 |
| 510k Number | K031864 |
| Device Name: | NITREX NITINOL GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | EV3 CORPORATION 4600 NATHAN LN. Plymouth, MN 55442 -2920 |
| Contact | Carolyn Anderson |
| Correspondent | Carolyn Anderson EV3 CORPORATION 4600 NATHAN LN. Plymouth, MN 55442 -2920 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-06-24 |
| Summary: | summary |