510(k) K030966 ยท NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
| Applicant | Boston Scientific Corp, Glens Falls NY, US |
| Decision | Substantially Equivalent, Sep 23, 2003 |
| Received | Mar 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2009 | Boston Scientific Corporation Boston Scientific, Contour SE Microspheres, for tumor treatment.
UPN Codes: Description:
M001761101 Contour SE/100-300/1mL/2vials
M001761122 Contour SE/100-300/1mL/5vials
M001761141 Contour SE/100-3 Terminated |
NAJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.