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FDA 510(k)

LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US

K-Number: K193473 · 2020-06-26

ApplicantBoston Scientific Corporation
Decision Date2020-06-26
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US 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 2020-06-26 under 510(k) number K193473. 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 Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US?

LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Boston Scientific Corporation. The 510(k) number is K193473.

When did LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US receive FDA 510(k) clearance?

LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US received FDA 510(k) clearance on 2020-06-26, under 510(k) number K193473.

Who is the listed applicant for LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US?

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 Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US?

The FDA product code for LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US 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_RECRUITINGNCT07502599Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)RECRUITINGNCT01385176Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)ACTIVE_NOT_RECRUITINGNCT01550575Patient Retrospective Outcomes (PRO)RECRUITINGNCT01719055RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for PainRECRUITINGNCT02071134Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS RegistryRECRUITING

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Related Devices (Code: MXD)

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.

K261074BIOMONITOR IV (471155)Biotronik, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICALK251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)AbbottK252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific CorporationK240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.K233562LINQ II Insertable Cardiac MonitorMedtronic, 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.

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