Cleared Traditional

Assert-IQ? Insertable Cardiac Monitor

K230286 · Abbott Medical · Cardiovascular

May 2023

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K230286 is an FDA 510(k) clearance for the Assert-IQ? Insertable Cardiac Monitor, a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II — Special Controls, product code MXC), submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on May 17, 2023, 104 days after receiving the submission on February 2, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K230286 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2023
Decision Date	May 17, 2023
Days to Decision	104 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