510(k) K252917 ยท PZX Left Atrial Appendage Clip, Implantable
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
| Applicant | Genesee Biomedical, Inc., Denver CO, US |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Sep 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252917
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.