LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)— 510(k) K252593

Name: FDA 510(k) clearance K252593
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K252593 for LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312), Substantially Equivalent on 2025-09-12. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code MXD
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2025-08-15
Decision date: 2025-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MXD

product code MXD

Injury: 1,880
Malfunction: 9,487
Total: 11,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.