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FDA 510(k)

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

K-Number: K210484 · 2021-06-11

ApplicantMedtronic, Inc.
Decision Date2021-06-11
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2021-06-11 under approval number K210484. 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, Zelda AI ECG Classification System?

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is a medical device that received FDA 510(k) clearance on 2021-06-11. It is manufactured by Medtronic, Inc.. The 510(k) number is K210484.

When was LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System approved by the FDA?

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System received FDA 510(k) clearance on 2021-06-11, under approval number K210484.

What company makes LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System?

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is manufactured by Medtronic, Inc..

What is the FDA product code for LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System?

The FDA product code for LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is MXD.

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Related PubMed Literature

PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024)

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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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