510(k) K023248 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
| Applicant | Orbus Medical Technologies, Fort Lauderdale FL, US |
| Decision | Unknown, Feb 11, 2003 |
| Received | Sep 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Orbus Medical Technologies Inc The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree.
The product is labeled as Edwa Terminated |
MEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.