510(k) K172081 ยท KRA Catheter, Continuous Flush
Maestro Microcatheter
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Aug 4, 2017 |
| Received | Jul 10, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2024 | Merit Medical Systems, Inc. Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B,
28MC21110ST/B,
28MC2113045/B,
28MC21130SN/CNB,
28MC21130ST/B,
28MC2115045/B,
28MC2115045/C,
28MC21150SN/B,
28MC21150ST/B,
28MC2411045/D, Open, Classified |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.