FDA 510(k)

Reveal LINQ

K-Number: K160689 · 2016-04-22

Decision Date2016-04-22

Product CodeMXD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Reveal LINQ is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2016-04-22 under approval number K160689. 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 2016-04-22. It is manufactured by Medtronic, Inc.. The 510(k) number is K160689.

When was Reveal LINQ approved by the FDA?

Reveal LINQ received FDA 510(k) clearance on 2016-04-22, under approval number K160689.

What company makes Reveal LINQ?

Reveal LINQ is manufactured by Medtronic, Inc..

What is the FDA product code for Reveal LINQ?

The FDA product code for Reveal LINQ is MXD.

Other Devices by Medtronic, Inc.

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Related Devices (Code: MXD)

K160809Reveal LINQMedtronic, Inc. K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc. K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. K162855Reveal LINQMedtronic, Inc. K163460Reveal LINQ 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.