Cleared Traditional

Confirm Rx Insertable Cardiac Monitor

K202888 · Abbott (St. Jude Medical) · Cardiovascular

Nov 2020

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K202888 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 (St. Jude Medical) (Sylmar, US). The FDA issued a Cleared decision on November 23, 2020, 56 days after receiving the submission on September 28, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K202888 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2020
Decision Date	November 23, 2020
Days to Decision	56 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