FDA 510(k)

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)

K-Number: K252593 · 2025-09-12

Decision Date2025-09-12

Product CodeMXD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K252593. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)?

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Boston Scientific Corporation. The 510(k) number is K252593.

When did LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) receive FDA 510(k) clearance?

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252593.

Who is the listed applicant for LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)?

The FDA product code for LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) is MXD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04790344LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.ACTIVE_NOT_RECRUITING NCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITING NCT01550575Patient Retrospective Outcomes (PRO)RECRUITING NCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITING NCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITING NCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITING

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Related Devices (Code: MXD)

K261074BIOMONITOR IV (471155)Biotronik, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICAL K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.