510(k) K162988 ยท DXC Clamp, Vascular
PreludeSYNC Radial Compression Device
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Jan 25, 2017 |
| Received | Oct 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2017 | Merit Medical Systems, Inc. The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization proce Terminated |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.