510(k) K010068 ยท ESW Prosthesis, Esophageal
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
| Applicant | Rusch Intl., Jaffrey NH, US |
| Decision | Substantially Equivalent, Feb 8, 2001 |
| Received | Jan 8, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 20/16mm x 90mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 20/16mm x 120mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 20/16mm x 150mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 23/18mm x 90mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 23/18mm x 120mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 23/18mm x 150mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 25/21mm x 90mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 25/21mm x 120mm Terminated |
ESW | None listed |
| May 14, 2003 | Boston Scientific Corporation Polyflex Esophageal Stent 25/21mm x 150mm Terminated |
ESW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.