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Cardiotrode

by Kholber Corp.

510(k) K840646

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840646 Date26 Oct 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
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 Cardiotrode is a medical device classified under product code DRX, intended for use in cardiac monitoring and electrophysiological studies. It functions as an electrode system designed to record and transmit electrical signals from the heart, aiding in diagnostic assessments and procedural guidance during cardiac interventions.

Supplied as a reusable device, the Cardiotrode is regulated under FDA 510(k) clearance (K840646), with a traditional review process through the Cardiovascular (CV) advisory committee. It was authorized in 1984 and remains subject to compliance with U.S. regulatory standards for medical devices. No additional sterility or MRI safety specifications are noted in the available data.

Questions

AI-generated answers, 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.

  • What is the Cardiotrode device used for?

    The Cardiotrode is an electrode system designed to record and transmit electrical signals from the heart, used in cardiac monitoring and electrophysiological studies to aid in diagnostic assessments and procedural guidance during cardiac interventions.

  • Is the Cardiotrode a single-use or reusable device?

    The Cardiotrode is supplied as a reusable device, meaning it can be used multiple times for cardiac monitoring and electrophysiological studies as per the manufacturer's instructions.

  • What is the regulatory status of the Cardiotrode?

    The Cardiotrode is regulated under FDA 510(k) clearance (K840646) with a traditional review process through the Cardiovascular advisory committee, authorized in 1984 and subject to compliance with U.S. regulatory standards.

  • Are there any specific storage requirements for the Cardiotrode?

    The available data does not specify particular storage requirements for the Cardiotrode, so standard medical device storage practices should be followed unless otherwise specified by the manufacturer.