The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Preludesync Radial Compression Device.
| Device ID | K162988 |
| 510k Number | K162988 |
| Device Name: | PreludeSYNC Radial Compression Device |
| Classification | Clamp, Vascular |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Ileana Davis |
| Correspondent | Ileana Davis Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-27 |
| Decision Date | 2017-01-25 |
| Summary: | summary |