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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 a medical device manufactured by Boston Scientific Corp. It received FDA 510(k) clearance on 2023-08-19 under approval 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. It is manufactured by Boston Scientific Corp. The 510(k) number is K231328.

When was LUX-Dx II (M302); LUX-Dx II+ (M312) approved by the FDA?

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

What company makes LUX-Dx II (M302); LUX-Dx II+ (M312)?

LUX-Dx II (M302); LUX-Dx II+ (M312) is manufactured by Boston Scientific Corp.

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.

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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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