510(k) K153771 ยท DYB Introducer, Catheter
TXM Guiding Sheath
| Applicant | Texasmedical Technologies, Inc., El Paso TX, US |
| Decision | Substantially Equivalent, Sep 13, 2016 |
| Received | Dec 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153771
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.