Cleared Traditional

Confirm Rx Insertable Cardiac Monitor

K190295 · Abbott (St. Jude Medical) · Cardiovascular

Apr 2019

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K190295 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 April 10, 2019, 58 days after receiving the submission on February 11, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K190295 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2019
Decision Date	April 10, 2019
Days to Decision	58 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