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FDA 510(k)

LINQ II Insertable Cardiac Monitor

K-Number: K221962 · 2022-08-25

ApplicantMedtronic, Inc.
Decision Date2022-08-25
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LINQ II Insertable Cardiac Monitor is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2022-08-25 under approval number K221962. 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 LINQ II Insertable Cardiac Monitor?

LINQ II Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Medtronic, Inc.. The 510(k) number is K221962.

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

LINQ II Insertable Cardiac Monitor received FDA 510(k) clearance on 2022-08-25, under approval number K221962.

What company makes LINQ II Insertable Cardiac Monitor?

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

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

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

Related Clinical Trials

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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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