510(k) K210685 ยท DYB Introducer, Catheter
AcQCross Qx Integrated Transseptal Dilator/Needle
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 6, 2021 |
| Received | Mar 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210685
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.