The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Scout Bx Delivery System.
| Device ID | K212882 |
| 510k Number | K212882 |
| Device Name: | SCOUT BX Delivery System |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
| Contact | Sari Stevens |
| Correspondent | Sari Stevens Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2022-04-08 |