Cleared Traditional

Confirm Rx Insertable Cardiac Monitor

K182981 · Abbott · Cardiovascular

Mar 2019

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K182981 is an FDA 510(k) clearance for the Confirm Rx Insertable Cardiac Monitor, a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II — Special Controls, product code MXC), submitted by Abbott (Sylmar, US). The FDA issued a Cleared decision on March 29, 2019, 151 days after receiving the submission on October 29, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K182981 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 29, 2018
Decision Date	March 29, 2019
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2800