510(k) K032930 ยท ESW Prosthesis, Esophageal
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Oct 23, 2003 |
| Received | Sep 22, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032930
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/7. Catalog Number M00513700. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumin Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/10. Catalog Number M00513710. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number M00513720. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/10/7. Catalog Number M00513730. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/12/9. Catalog Number M00513740. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lumi Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/15/12. Catalog Number M00513750. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lum Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/7. Catalog Number M00513800. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lum Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/10. Catalog Number M00513810. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/15. Catalog Number M00513830. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/10/7. Catalog Number M00513840. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/12/9. Catalog Number M00513850. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/15/12. Catalog Number M00513860. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal l Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/10/7. Catalog Number M00514200. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophag Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/12/9. Catalog Number M00514210. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophag Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/10/7. Catalog Number M00514240. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esoph Terminated |
ESW | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/12/9. Catalog Number M00514250. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esoph Terminated |
ESW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.