510(k) K021901 ยท JCT Prosthesis, Tracheal, Expandable
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
| Applicant | Boston Scientific Scimed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Jul 9, 2002 |
| Received | Jun 10, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2011 | Boston Scientific Corporation Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, Galway, IRELAND, STERILE, EO.
The WALLGRAFT Tracheobronchial Endoprosthesis is i Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.