MICRUS GUIDE WIRE, WATUSI 0.014
FDA 510(k) clearance K053265 · decided 2006-04-28
Clearance details
- K-number
- K053265
- Device name
- MICRUS GUIDE WIRE, WATUSI 0.014
- Applicant
- Micrus Endovascular Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-11-22
- Decision date
- 2006-04-28
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distribut recall (Z-1542-06) | Micrus Endovascular Corporation | 2006-09-29 |