510(k) K973230 ยท DXT Injector And Syringe, Angiographic
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Nov 25, 1997 |
| Received | Aug 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973230
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit. Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.