510(k) K210331 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
CardiaMend Pericardial and Epicardial Reconstruction Matrix
| Applicant | Helios Cardio, Inc., Weston MA, US |
| Decision | Substantially Equivalent, Dec 21, 2021 |
| Received | Feb 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210331
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.