# K030141: Modification to Cardiovention Powerbase Console, Model PCB-100

- Pathway: 510(k) (Special)
- Applicant: Cardiovention, Inc.
- Decided: Feb 26, 2003 after 42 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991864 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021694: Cardiovention Powerbase Console, Model PBC-100, Cardiovention, Inc. (2003)
- K012325: Cardiovention Corx System, Model FG 0001, Cardiovention, Inc. (2002)

## Indications for use
The CardioVention PowerBaseTMConsole is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six Iiterdminute and lasting for up to six hours.

Source page: https://510kreport.com/device/K030141
Methodology: https://510kreport.com/methodology