510(k) K010002 ยท FAD Stent, Ureteral
CONTOUR POLARIS URETERAL STENT
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jan 22, 2001 |
| Received | Jan 2, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2006 | Boston Scientific Corp Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent. Terminated |
FAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.