The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus One 2 One Guidewire, Micrus One 2 One Soft Guidewire.
| Device ID | K102818 |
| 510k Number | K102818 |
| Device Name: | MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Contact | Patrick Lee |
| Correspondent | Patrick Lee MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-28 |
| Decision Date | 2010-12-03 |