510(k) K141584 ยท JCT Prosthesis, Tracheal, Expandable
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Oct 16, 2014 |
| Received | Jun 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2016 | Boston Scientific Corporation Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm
Material Number: M00576550
The stent system is a permanently implanted expandable metal stent designed for pallia Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.