510(k) K170951 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
CardioCel 3D
| Applicant | Admedus Regen Pty, Ltd., Malaga, AU |
| Decision | Substantially Equivalent, Apr 28, 2017 |
| Received | Mar 31, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170951
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.