# K020106: Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Apr 10, 2002 after 89 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896807 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896807: SPBC Series Single Pass Blood Cardioplegia System, Gish Biomedical, Inc. (1990) Summary page 1.
- K934763: Sorin Blood Cardioplegia System, Sorin Biomedical, Inc. (1994) Summary page 1.

## Most influential descendants
- K081838: Gish Vision Blood Cardioplegia with HA Coating (2009), 0 descendants of its own
- K040355: Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS Coating (2004), 0 descendants of its own

## Indications for use
The Vision Blood Cardioplegia 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 of hypothermic applications.

Source page: https://510kreport.com/device/K020106
Methodology: https://510kreport.com/methodology