Cleared Special

LINQ II Insertable Cardiac Monitor

K233562 · Medtronic, Inc. · Cardiovascular

Dec 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K233562 is an FDA 510(k) clearance for the LINQ II Insertable Cardiac Monitor, 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 December 6, 2023, 30 days after receiving the submission on November 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K233562 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2023
Decision Date	December 06, 2023
Days to Decision	30 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