510(k) K192106 ยท DYB Introducer, Catheter
AcQRef Introducer Sheath
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 3, 2019 |
| Received | Aug 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192106
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.