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FDA 510(k)

Reveal LINQ Insertable Cardiac Monitor

K-Number: K212008 · 2021-07-22

ApplicantMedtronic, Inc.
Decision Date2021-07-22
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reveal LINQ Insertable Cardiac Monitor is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2021-07-22 under approval number K212008. 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 Insertable Cardiac Monitor?

Reveal LINQ Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Medtronic, Inc.. The 510(k) number is K212008.

When was Reveal LINQ Insertable Cardiac Monitor approved by the FDA?

Reveal LINQ Insertable Cardiac Monitor received FDA 510(k) clearance on 2021-07-22, under approval number K212008.

What company makes Reveal LINQ Insertable Cardiac Monitor?

Reveal LINQ Insertable Cardiac Monitor is manufactured by Medtronic, Inc..

What is the FDA product code for Reveal LINQ Insertable Cardiac Monitor?

The FDA product code for Reveal LINQ Insertable Cardiac Monitor is MXD.

Related Clinical Trials

NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING NCT03505801 Confirm Rx Insertable Cardiac Monitor SMART Registry COMPLETED

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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. K162855Reveal LINQMedtronic, 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.

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