510(k) K252593 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
| Applicant | Boston Scientific Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, Sep 12, 2025 |
| Received | Aug 15, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252593
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.