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Confirm Rx Insertable Cardiac Monitor

by Abbott (St. Jude Medical) 3 variants

510(k) K190295

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190295 Date10 Apr 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MXC
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Confirm Rx Insertable Cardiac Monitor DM3500 is an Implantable Cardiac Recorder (Without Arrhythmia Detection) per FDA nomenclature (Device Class II, Product Code MXC). This device is designed for long-term, continuous monitoring of cardiac electrical activity, enabling remote transmission of electrogram (EGM) data to aid in diagnosing cardiac arrhythmias and unexplained symptoms in patients.

The device is implanted via a minimally invasive procedure and communicates wirelessly via Bluetooth for remote data transfer. Supplied sterile and intended for single-use, it operates in non-MRI environments (MR Conditional status not applicable per specifications). Authorized under FDA 510(k) clearance (K190295), it is regulated under 870.2800 and distributed with model-specific reference codes (e.g., 3002623849). Storage and handling follow standard sterile medical device protocols.

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