The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Elation Wireguided Balloon Dilation Catheter.
| Device ID | K151925 |
| 510k Number | K151925 |
| Device Name: | Elation Wireguided Balloon Dilation Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PARKWAY South Jordan, UT 84095 |
| Contact | David Thomas |
| Correspondent | David Thomas MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PARKWAY South Jordan, UT 84095 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2015-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450399368 | K151925 | 000 |
| 20884450258006 | K151925 | 000 |
| 10884450258016 | K151925 | 000 |
| 20884450258037 | K151925 | 000 |
| 20884450258068 | K151925 | 000 |
| 10884450258078 | K151925 | 000 |
| 20884450258082 | K151925 | 000 |
| 10884450258092 | K151925 | 000 |
| 10884450258108 | K151925 | 000 |
| 10884450258115 | K151925 | 000 |
| 20884450258129 | K151925 | 000 |
| 20884450258136 | K151925 | 000 |
| 10884450258146 | K151925 | 000 |
| 10884450399351 | K151925 | 000 |