510(k) K943597 ยท MAV Syringe, Balloon Inflation
MONARCH AP(TM)
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Feb 10, 1995 |
| Received | Jul 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943597
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.