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Antegrade/Retrograde Cardioplegia Valve Systems

by Gish Biomedical, Inc.

510(k) K922840

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 NumberK922840 Date17 May 1993ClearedStatusActive

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  • Withdrawn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
DTL
Device Class
Class II
Regulation
21 CFR Part 870.4290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

An Antegrade/Retrograde Cardioplegia Valve System is a cardiovascular device classified as an adaptor, stopcock, manifold, fitting, and cardiopulmonary bypass component. It is designed for use in cardioplegia delivery during cardiac surgery, allowing both antegrade and retrograde administration of cardioplegic solution and blood.

The system is supplied as a reusable device and requires cleaning and sterilization between uses. It is indicated for use in cardiovascular surgical settings and is subject to special controls under FDA 510(k) clearance K922840, with product code DTL and device class II.

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Questions

AI-generated answers, 6 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 Antegrade/Retrograde Cardioplegia Valve System used for?

    The Antegrade/Retrograde Cardioplegia Valve System is designed for use in cardioplegia delivery during cardiac surgery, allowing both antegrade and retrograde administration of cardioplegic solution and blood to protect the heart muscle during procedures requiring cardiopulmonary bypass.

  • Is the Antegrade/Retrograde Cardioplegia Valve System reusable or single-use?

    The system is supplied as a reusable device and requires cleaning and sterilization between uses, as stated in the device description, to ensure safe repeated application in cardiovascular surgical settings.

  • What regulatory pathway was used for the Antegrade/Retrograde Cardioplegia Valve System?

    The device received FDA 510(k) clearance under K922840, classified as substantially equivalent to a predicate device, and is subject to special controls for its device class II classification under product code DTL.