Cleared Special

Confirm Rx Insertable Cardiac Monitor

K192593 · Abbott · Cardiovascular

Oct 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K192593 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 October 18, 2019, 28 days after receiving the submission on September 20, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K192593 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2019
Decision Date	October 18, 2019
Days to Decision	28 days
Submission Type	Special
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