510(k) K211100 ยท DRA Catheter, Steerable
AcQGuide MAX Steerable Sheath
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 14, 2021 |
| Received | Apr 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211100
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.