510(k) K072720 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
| Applicant | Alveolus, Inc., Charlotte NC, US |
| Decision | Unknown, Apr 11, 2008 |
| Received | Sep 25, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neopl Terminated |
FGE | None listed |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neopl Terminated |
FGE | None listed |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neopl Terminated |
FGE | None listed |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x 40, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neop Terminated |
FGE | None listed |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neop Terminated |
FGE | None listed |
| Feb 22, 2010 | Merit Medical Systems, Inc. Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Intended for palliation of malignant neop Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.