510(k) K170668 ยท DYB Introducer, Catheter
HeartSpan Steerable Sheath Introducer
| Applicant | Merit Medical Systems, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | Mar 6, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170668
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.