The following data is part of a premarket notification filed by Merit Medical System, Inc. with the FDA for Merit Siege Vascular Plug.
| Device ID | K212817 |
| 510k Number | K212817 |
| Device Name: | Merit Siege Vascular Plug |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Merit Medical System, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Mark Mullaney |
| Correspondent | Siobhan King Merit Medical System, Inc. Parkmore Business Park West Galway, IE |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2021-12-15 |