# K093832: Levitronix Centrimag Primary and Backup Consoles

- Pathway: 510(k) (Special)
- Applicant: Levitronix, LLC
- Decided: Jan 13, 2010 after 30 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K852698 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console, Levitronix, LLC (2008) Summary page 1.
- K090004: Levitronix, Thoratec Centrimag Back-UP Consoles, Levitronix, LLC (2009) Summary page 1.

## Indications for use
The Levitronix CentriMag Primary and Back-Up Consoles are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System, The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeall circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

Source page: https://510kreport.com/device/K093832
Methodology: https://510kreport.com/methodology