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510(k) Data Aggregation
K Number
K212008Device Name
Reveal LINQ Insertable Cardiac Monitor
Manufacturer
Medtronic. Inc.
Date Cleared
2021-07-22
(24 days)
Product Code
MXD
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
Medtronic. Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reveal LINQ ICM is an insertable automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
- patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
Device Description
The Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINQ ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM. The Reveal LINO ICM Model LNO11 is a small. leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.
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