The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Guide Wire, Watusi 0.014.
| Device ID | K053265 |
| 510k Number | K053265 |
| Device Name: | MICRUS GUIDE WIRE, WATUSI 0.014 |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 610 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Contact | Margaret Webber |
| Correspondent | Margaret Webber MICRUS ENDOVASCULAR CORPORATION 610 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-22 |
| Decision Date | 2006-04-28 |
| Summary: | summary |