510(k) K220047 ยท DYB Introducer, Catheter
AcQCross Qx Integrated Transseptal Dilator/Needle
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 8, 2022 |
| Received | Jan 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220047
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.