510(k) K180723 ยท DXC Clamp, Vascular
PreludeSYNC DISTAL Radial Compression System
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Mar 19, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2020 | Merit Medical Systems, Inc. PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.