510(k) K091816 ยท ESW Prosthesis, Esophageal
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jul 1, 2009 |
| Received | Jun 18, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15)
Material/Catalog Number: M00513720. Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Distal Release Distal Release (18/23/12/9)
Material/UPN/Catalog Number: M00513740 Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Uncovered Esophageal Stent System - Proximal Release (18/23/7) Material/UPN/Catalog Number: M00513800 Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/10/7)
Material/UPN/Catalog Number: M00513840 Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/12/9)
Material/UPN/Catalog Number: M00513850 Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/15/12)
Material/UPN/Catalog Number: M00513860 Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7)
Material/UPN/Catalog Number: M00514200 Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Uncovered Large Esophageal Stent System - Distal Release (23/28/12)
Material/UPN/Catalog Number: M00514230 Terminated |
ESW | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Large Esophageal Stent System - Proximal Release (23/28/12/9)
Material/UPN/Catalog Number: M00514250 Terminated |
ESW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.