510(k) K945494 ยท JCT Prosthesis, Tracheal, Expandable
WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS
| Applicant | Boston Scientific Scimed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Mar 3, 1995 |
| Received | Nov 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2011 | Boston Scientific Corporation Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO.
Ind Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.