Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LUX-Dx II (M302); LUX-Dx II+ (M312)

K-Number: K231328 · 2023-08-19

ApplicantBoston Scientific Corp
Decision Date2023-08-19
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUX-Dx II (M302); LUX-Dx II+ (M312) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2023-08-19 under 510(k) number K231328. 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 (M302); LUX-Dx II+ (M312)?

LUX-Dx II (M302); LUX-Dx II+ (M312) is a medical device that received FDA 510(k) clearance on 2023-08-19. The listed applicant is Boston Scientific Corp. The 510(k) number is K231328.

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

LUX-Dx II (M302); LUX-Dx II+ (M312) received FDA 510(k) clearance on 2023-08-19, under 510(k) number K231328.

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

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

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

The FDA product code for LUX-Dx II (M302); LUX-Dx II+ (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.

NCT01385176Neural 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 RegistryRECRUITINGNCT02686125Vercise™ DBS Dystonia Prospective StudyRECRUITINGNCT02928497Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral AnticoagulationTERMINATED

Other records listing Boston Scientific Corp as applicant

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.

K262406EluPro Antibiotic-Eluting BioEnvelopePMA P150031Stimulator, electrical, implanted, for parkinsonian symptomsPMA P030017Stimulator, spinal-cord, totally implanted for pain reliefPMA P190006Implanted electrical device intended for treatment of fecal incontinencePMA P180046Stimulator, electrical, implantable, for incontinencePMA P180011Stent, superficial femoral artery, drug-eluting

View all 251 devices →

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.

↑