The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Alimaxx-b Uncovered Biliary Stent System Endoscopic.
| Device ID | K093947 |
| 510k Number | K093947 |
| Device Name: | ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Carol Holloway, Rac |
| Correspondent | Carol Holloway, Rac MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450031107 | K093947 | 000 |
| 10884450031091 | K093947 | 000 |
| 10884450031084 | K093947 | 000 |
| 10884450031077 | K093947 | 000 |
| 10884450031060 | K093947 | 000 |
| 10884450031053 | K093947 | 000 |