510(k) K152194 ยท DYB Introducer, Catheter
transGlide Expandable Introducer
| Applicant | Transaortic Medical, Inc., Morgan Hill CA, US |
| Decision | Substantially Equivalent, Apr 7, 2016 |
| Received | Aug 5, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152194
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.