PIVOT STEERABLE MICROCATHETER
FDA 510(k) clearance K050630 · decided 2005-03-22
Clearance details
- K-number
- K050630
- Device name
- PIVOT STEERABLE MICROCATHETER
- Applicant
- Boston Scientific - Precision Vascular
- Decision
- Substantially Equivalent
- Date received
- 2005-03-11
- Decision date
- 2005-03-22
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- 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 Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Univers recall (Z-0895-06) | Boston Scientific Target | 2006-05-23 |