# K131179: Centrimag Primary Console (2ND Generation); Mag Monitor

- Pathway: 510(k) (Special)
- Applicant: Thoratec Corp
- Decided: Jul 18, 2013 after 84 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K852698 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100, Levitronix, LLC (2003) Summary page 1.
- K102129: Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor, Levitronix, LLC (2010) Summary page 1.

## Recalls of this device
- Sep 5, 2018 · Class II · Z-0103-2019: Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable

## Indications for use
The 2nd Generation CentriMag Primary Console and Mag Monitor are indicated for use with the CentriMag Extracorporeal Blood Pumping System. The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal 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/K131179
Methodology: https://510kreport.com/methodology