510(k) K181038 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
| Applicant | Cormatrix Cardiovascular, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Oct 10, 2018 |
| Received | Apr 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181038
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.