510(k) K140338 ยท DYB Introducer, Catheter
CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)
| Applicant | Creganna-Tactx Medical, Galway, IE |
| Decision | Substantially Equivalent, Aug 27, 2014 |
| Received | Feb 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140338
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.