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D6ZO Disposable Heat Exchanger

by Electromedics, Inc.

510(k) K813264

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 NumberK813264 Date6 Jul 1982ClearedStatusActive

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  • Withdrawn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
DTR
Device Class
Class II
Regulation
21 CFR Part 870.4240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 D6zo Disposable Heat Exchanger is a heat-exchanger, cardiopulmonary bypass device used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device. It is classified as a device class 2 and is used in the medical specialty of Cardiovascular. The device consists of a heat exchange system.

The D6zo Disposable Heat Exchanger is supplied as a disposable device and is regulated under the product code DTR. It has been cleared by the FDA under the 510(k) number K813264, with a decision date of 1982-07-06. The device is intended for single-use and is stored according to the manufacturer's instructions. It is designed for use in a cardiopulmonary bypass setting.

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Questions

AI-generated answers, 24 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 D6ZO Disposable Heat Exchanger used for?

    The D6ZO Disposable Heat Exchanger is used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device, specifically in cardiopulmonary bypass settings.

  • Is the D6ZO Disposable Heat Exchanger reusable?

    No, the D6ZO Disposable Heat Exchanger is intended for single-use and is supplied as a disposable device.

  • How is the D6ZO Disposable Heat Exchanger stored?

    The device is stored according to the manufacturer's instructions.

  • What regulatory clearance does the D6ZO Disposable Heat Exchanger have?

    The D6ZO Disposable Heat Exchanger has been cleared by the FDA under the 510(k) number K813264.