510(k) K191734 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
MatriStem UBM Pericardial Patch
| Applicant | Acell, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Jun 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191734
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.