FDA 510(k)

Reveal LINQ

K-Number: K162855 · 2017-02-23

Decision Date2017-02-23

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 2017-02-23 under approval 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. It is manufactured by Medtronic, Inc.. The 510(k) number is K162855.

When was Reveal LINQ approved by the FDA?

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

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.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162054Medtronic Temporary External Pacemaker 53401 K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement

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Related Devices (Code: MXD)

K160809Reveal LINQMedtronic, Inc. K160689Reveal 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. 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.