PV 1900 SYNCHRO 0.016 GUIDEWIRE
FDA 510(k) clearance K050964 · decided 2005-06-13
Clearance details
- K-number
- K050964
- Device name
- PV 1900 SYNCHRO 0.016 GUIDEWIRE
- Applicant
- Boston Scientific - Precision Vascular
- Decision
- Substantially Equivalent
- Date received
- 2005-04-18
- Decision date
- 2005-06-13
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Valley City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip; Boston Scientific Corporation: recall (Z-0876-2011) | Boston Scientific Corporation | 2011-01-07 |
| Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip; Boston Scientific Corporation: recall (Z-0877-2011) | Boston Scientific Corporation | 2011-01-07 |
| Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientifi recall (Z-0878-2011) | Boston Scientific Corporation | 2011-01-07 |
| Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip; Boston Scientifi recall (Z-0879-2011) | Boston Scientific Corporation | 2011-01-07 |
| Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip; Boston Scientifi recall (Z-0880-2011) | Boston Scientific Corporation | 2011-01-07 |
| Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientifi recall (Z-0881-2011) | Boston Scientific Corporation | 2011-01-07 |