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Vasogenics EECP-MC2

by Vasogenics, Inc.

510(k) K940264

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 NumberK940264 Date23 Feb 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  • Withdrawn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
DRN
Device Class
Class II
Regulation
21 CFR Part 870.5225
Advisory Committee
Cardiovascular
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 Vasogenics Eecp-Mc2 is a Device, Counter-Pulsating, External, used in the Cardiovascular medical specialty. It is classified as a class 2 device. The device is substantially equivalent to a predicate device. The Vasogenics Eecp-Mc2 is designed to provide external counterpulsation therapy.

The Vasogenics Eecp-Mc2 is supplied with a product code of DRN and a regulation number of 870.5225. It has been cleared by the FDA with a 510(k) number of K940264. The device is intended for use in a cardiovascular setting and is a single device, not a system or kit. It is not specified if the device is sterile, single-use, or reusable, or if it has any specific storage requirements.

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 Vasogenics EECP-MC2 used for?

    The Vasogenics EECP-MC2 is used to provide external counterpulsation therapy in a cardiovascular setting, which helps to improve blood flow and reduce the workload on the heart.

  • Is the Vasogenics EECP-MC2 a single-use or reusable device?

    The device specifications do not explicitly state whether the Vasogenics EECP-MC2 is single-use or reusable, and its sterility and storage requirements are also not specified.

  • What is the regulatory status of the Vasogenics EECP-MC2?

    The Vasogenics EECP-MC2 has been cleared by the FDA with a 510(k) number of K940264, indicating that it is substantially equivalent to a predicate device.

  • What medical specialty is the Vasogenics EECP-MC2 intended for?

    The Vasogenics EECP-MC2 is intended for use in the cardiovascular medical specialty.