# K072583: Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Apr 4, 2008 after 204 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: 4 generations back to K932252 (1993). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012898: Modification to: CSC14 Blood Cardioplegia System, Cobe Cardiovascular, Inc. (2001)
- K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32, Maquet Cardiopulmonary, AG (2006) Summary page 1.

## Most influential descendants
- K090555: Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 (2009), 1 descendant of its own
- K112360: Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane Oxygenators Series (2011), 0 descendants of its own

## Indications for use
The Plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.

Source page: https://510kreport.com/device/K072583
Methodology: https://510kreport.com/methodology