510(k) K132164 ยท DYB Introducer, Catheter
HEARTSPAN STEERABLE INTRODUCER KIT
| Applicant | Merit Medical Systems, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Sep 17, 2013 |
| Received | Jul 12, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132164
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.