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Heparin Assay Cartridges And Controls

by Medtronic Hemotec, Inc.

510(k) K944115

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 NumberK944115 Date24 Mar 1995ClearedStatusActive

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  • Withdrawn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
GFT
Device Class
Class II
Regulation
21 CFR Part 864.7525
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Heparin Assay Cartridges And Controls are a device used to determine the level of the anticoagulant heparin in a patient's circulation. This device utilizes quantitative clotting time procedures to provide the necessary measurements. The device is classified under the medical specialty of Hematology. It is a type of device that falls under the product code GFT.

The Heparin Assay Cartridges And Controls are supplied by Medtronic Hemotec, Inc. and have been cleared with the FDA 510K number K944115. The device is intended for use in a clinical setting, specifically in the field of Hematology. The storage and handling of the device should be in accordance with the manufacturer's instructions. The device has a registration number and is classified as a class 2 device.

Other devices from Medtronic Hemotec, Inc.

Questions

AI-generated answers, 27 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 Heparin Assay Cartridges And Controls device used for?

    The Heparin Assay Cartridges And Controls device is used to determine the level of the anticoagulant heparin in a patient's circulation, utilizing quantitative clotting time procedures.

  • How is the Heparin Assay Cartridges And Controls device supplied?

    The device is supplied by Medtronic Hemotec, Inc. and is intended for use in a clinical setting, specifically in the field of Hematology.

  • What are the storage and handling requirements for the device?

    The storage and handling of the device should be in accordance with the manufacturer's instructions.

  • What is the classification of the Heparin Assay Cartridges And Controls device?

    The device is classified as a class 2 device under the product code GFT, and falls under the medical specialty of Hematology.