510(k) K152127 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CorMatrix Tyke
| Applicant | Cormatrix Cardiovascular, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Feb 4, 2016 |
| Received | Jul 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152127
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.