510(k) K152842 ยท JCT Prosthesis, Tracheal, Expandable
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, May 19, 2016 |
| Received | Sep 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized. Terminated |
JCT | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized. Terminated |
JCT | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized. Terminated |
JCT | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized. Terminated |
JCT | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized. Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.