510(k) K183635 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
PhotoFix Decellularized Bovine Pericardium
| Applicant | Cryolife, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Feb 14, 2019 |
| Received | Dec 26, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183635
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.