# K032068: Cardiovention Corx Ios-200 System, Model Ios-200

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovention, Inc.
- Decided: Aug 22, 2003 after 50 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0123251: CardioVention CORx System. Number could not be read

## Indications for use
The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.

Source page: https://510kreport.com/device/K032068
Methodology: https://510kreport.com/methodology