510(k) K970052 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
EXTRACTORRX
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Mar 25, 1997 |
| Received | Jan 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon
Catalog # 4544 Terminated |
None listed | |
| Feb 8, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon
Catalog # 4545 Terminated |
None listed | |
| Feb 8, 2003 | Boston Scientific Corporation Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon15.5 mm balloon
Catalog # 4546 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.