The following data is part of a premarket notification filed by Ev3 Neurovascular with the FDA for Meridian Guidewire.
| Device ID | K093681 |
| 510k Number | K093681 |
| Device Name: | MERIDIAN GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Deborah Baker-janis |
| Correspondent | Deborah Baker-janis EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-27 |
| Decision Date | 2010-01-26 |
| Summary: | summary |