# K040355: Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Mar 15, 2004 after 32 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896807 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020106: Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger, Gish Biomedical, Inc. (2002) Summary page 1.

## Recalls of this device
- Nov 28, 2005 · Not classified · Z-0575-06: The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.

## Indications for use
The Vision Blood Cardioplegia System with GBS™ coating is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit. The device may be used for normothermic or hypothermic applications. It is designed to operate at flow rates of one hundred (100) to six hundred (600) milliliters per minute for periods up to six (6.0) hours.

Source page: https://510kreport.com/device/K040355
Methodology: https://510kreport.com/methodology