Cleared Special

LINQ II? Insertable Cardiac Monitor (ICM)

K240693 · Medtronic, Inc. · Cardiovascular

Mar 2024

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K240693 is an FDA 510(k) clearance for the LINQ II? Insertable Cardiac Monitor (ICM), a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II — Special Controls, product code MXD), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 28, 2024, 15 days after receiving the submission on March 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K240693 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2024
Decision Date	March 28, 2024
Days to Decision	15 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1025