K252593
- 510(k) number
- K252593
- Device name
- LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- MXD — Recorder, Event, Implantable Cardiac, (With Arrhythm
- Decision date
- 2025-09-12
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252593.pdf
Official FDA record: K252593
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.