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FDA 510(k)

LUX-Dx Insertable Cardiac Monitor

K-Number: K210608 · 2021-05-25

ApplicantBoston Scientific Corporation
Decision Date2021-05-25
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUX-Dx Insertable Cardiac Monitor is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-05-25 under approval number K210608. 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?

LUX-Dx Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2021-05-25. It is manufactured by Boston Scientific Corporation. The 510(k) number is K210608.

When was LUX-Dx Insertable Cardiac Monitor approved by the FDA?

LUX-Dx Insertable Cardiac Monitor received FDA 510(k) clearance on 2021-05-25, under approval number K210608.

What company makes LUX-Dx Insertable Cardiac Monitor?

LUX-Dx Insertable Cardiac Monitor is manufactured by Boston Scientific Corporation.

What is the FDA product code for LUX-Dx Insertable Cardiac Monitor?

The FDA product code for LUX-Dx Insertable Cardiac Monitor is MXD.

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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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