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Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with Gbs Coating

by Gish Biomedical, Inc.

510(k) K040355

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK040355 Date15 Mar 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0575-06 FDA Unclassified (pre-2012) initiated 28 Nov 2005 on shared 510(k) K040355

    The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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 Vision Blood Cardioplegia System with GBS coating is a device used for control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. It is designed to operate at flow rates of 100 to 600 milliliters and may be used for normothermic or hypothermic applications. The system consists of an extracorporeal heat exchanger and fluid administration set.

The device is supplied as a single-use system and is regulated under FDA 510(k) clearance with product code DTR. It is manufactured by Gish Biomedical, Inc. and is intended for use in cardiovascular applications. The heat exchanger consists of a one-piece, stainless steel bellows configured as the primary element to effect heat exchange.

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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 Vision Blood Cardioplegia System used for?

    The Vision Blood Cardioplegia System is designed for temperature control of fluids such as blood or cardioplegia in extracorporeal circuits, typically used in cardiovascular applications for both normothermic and hypothermic procedures.

  • Is the Vision Blood Cardioplegia System single-use or reusable?

    The Vision Blood Cardioplegia System is supplied as a single-use system, meaning it should be used for one procedure and then discarded to ensure patient safety and device integrity.

  • What are the flow rate specifications for this device?

    The Vision Blood Cardioplegia System is designed to operate at flow rates ranging from 100 to 600 milliliters, making it suitable for various cardiovascular procedures requiring precise temperature control.

  • What is the regulatory status of the Vision Blood Cardioplegia System?

    The device is regulated under FDA 510(k) clearance with product code DTR, which means it has been determined to be substantially equivalent to predicate devices already on the market for cardiovascular applications.