510(k) K190882 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
XenoSure Biologic Patch
| Applicant | Lemaitre Vascular, Burlington MA, US |
| Decision | Substantially Equivalent, Feb 13, 2020 |
| Received | Apr 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190882
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.