# K021694: Cardiovention Powerbase Console, Model PBC-100

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovention, Inc.
- Decided: Jan 8, 2003 after 231 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: 2 generations back to K991864 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K936091: Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller, Medtronic Bio-Medicus, Inc. (1994) Summary page 1.
- K011838: Centrifugal Pump, Stockert Instrumente GmbH (2002)
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000) Summary page 1.

## Most influential descendants
- K030141: Modification to Cardiovention Powerbase Console, Model PCB-100 (2003), 0 descendants of its own

## 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 literdminute and lasting for up to six hours.

Source page: https://510kreport.com/device/K021694
Methodology: https://510kreport.com/methodology