The following data is part of a premarket notification filed by Ev3 Corporation with the FDA for X-sizer Catheter System.
| Device ID | K021096 |
| 510k Number | K021096 |
| Device Name: | X-SIZER CATHETER SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | EV3 CORPORATION 4600 NATHAN LN. Plymouth, MN 55442 -2920 |
| Contact | Jill Munsinger |
| Correspondent | Jill Munsinger EV3 CORPORATION 4600 NATHAN LN. Plymouth, MN 55442 -2920 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-04 |
| Decision Date | 2004-09-08 |
| Summary: | summary |