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CARDIOTEAM

by Cardiac Network, Inc.

510(k) K870527

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 NumberK870527 Date20 Apr 1987ClearedStatusActive

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  • Withdrawn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
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

CARDIOTEAM is a device classified as a Transmitter And Receiver, Electrocardiograph, Telephone, falling under the device class of 2. It is intended for use in cardiovascular applications, as indicated by its medical specialty description.

The device is supplied as a single-use item and is regulated under the regulation number 870.2920. It is not specified as sterile, and no information is provided regarding MRI safety, storage conditions, or specific sizes.

Questions

AI-generated answers, 1 Oct 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 Cardioteam device used for?

    The Cardioteam is a transmitter and receiver system designed specifically for electrocardiograph (ECG) telephony. It allows healthcare providers to transmit ECG readings over a telephone line, facilitating remote cardiovascular monitoring and diagnosis. This is particularly useful in situations where immediate on-site evaluation is not feasible, such as in rural areas or during emergencies.

  • Is the Cardioteam device single-use or reusable?

    The Cardioteam device is classified as a single-use item. This design ensures patient safety and hygiene, as each unit is intended for one-time use only before disposal. Single-use devices also reduce the risk of cross-contamination between patients, which is critical in clinical settings.

  • Is the Cardioteam device sterile?

    The provided information does not specify whether the Cardioteam device is sterile. If sterility is a requirement for your use case, it is important to verify this directly with the manufacturer, Cardiac Network, Inc., or consult their packaging instructions. Sterility is often critical for devices that come into direct contact with patients.

  • How is the Cardioteam device supplied?

    The Cardioteam device is supplied as a single-use unit, though the exact packaging details (e.g., whether it comes in a sealed pouch or box) are not specified in the provided data. Typically, single-use medical devices are packaged to maintain sterility and functionality until use. For precise storage and handling instructions, refer to the manufacturer’s documentation.

  • What regulatory pathway does the Cardioteam device follow?

    The Cardioteam device follows the FDA’s 510(k) clearance pathway, specifically under the regulation number 870.2920. This classification indicates that it has been determined to be substantially equivalent to a legally marketed device already on the market. The device is also associated with the product code DXH and falls under the Cardiovascular advisory committee, reflecting its intended use in cardiovascular applications.