The following data is part of a premarket notification filed by Brightwater Medical with the FDA for Convertx Biliary Stent System.
| Device ID | K181669 |
| 510k Number | K181669 |
| Device Name: | ConvertX Biliary Stent System |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BrightWater Medical 816 W. Bennett Ct. Dunlap, IL 61525 |
| Contact | Bob Smouse |
| Correspondent | Bob Smouse BrightWater Medical 42580 Rio Nedo Road Temecula, CA 92590 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-06-25 |
| Decision Date | 2019-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450442729 | K181669 | 000 |
| 10884450442743 | K181669 | 000 |
| 10884450442736 | K181669 | 000 |
| 10884450442712 | K181669 | 000 |
| 20884450458642 | K181669 | 000 |