BACK-UP MEIER GUIDEWIRE
FDA 510(k) clearance K011906 · decided 2001-08-13
Clearance details
- K-number
- K011906
- Device name
- BACK-UP MEIER GUIDEWIRE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2001-06-19
- Decision date
- 2001-08-13
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. Th recall (Z-1760-2010) | Boston Scientific Corporation | 2010-06-04 |