510(k) K980163 ยท JCT Prosthesis, Tracheal, Expandable
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
| Applicant | Boston Scientific Scimed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 13, 1998 |
| Received | Jan 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980163
| 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.