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510(k) K230553

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application by Medtronic, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2023
Date Received
February 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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Other clearances for product code MXD

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  • K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) (August 19, 2023)
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