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FDA 510(k)

Reveal LINQ

K-Number: K162855 · 2017-02-23

ApplicantMedtronic, Inc.
Decision Date2017-02-23
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reveal LINQ is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K162855. 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 Reveal LINQ?

Reveal LINQ is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Medtronic, Inc.. The 510(k) number is K162855.

When did Reveal LINQ receive FDA 510(k) clearance?

Reveal LINQ received FDA 510(k) clearance on 2017-02-23, under 510(k) number K162855.

Who is the listed applicant for Reveal LINQ?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reveal LINQ?

The FDA product code for Reveal LINQ is MXD.

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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.

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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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