CONTOUR POLARIS URETERAL STENT
FDA 510(k) clearance K010002 · decided 2001-01-22
Clearance details
- K-number
- K010002
- Device name
- CONTOUR POLARIS URETERAL STENT
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2001-01-02
- Decision date
- 2001-01-22
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- FAD
- Device class
- 2
- Regulation number
- 876.4620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-3 recall (Z-1238-06) | Boston Scientific Corp | 2006-07-13 |