# K083340: Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console

- Pathway: 510(k) (Special)
- Applicant: Levitronix, LLC
- Decided: Nov 26, 2008 after 14 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: 5 generations back to K852698 (1985). 8 ancestors in all.
9 later devices descend from it; 3 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console, Levitronix, LLC (2008) Summary page 1.

## Most influential descendants
- K102129: Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor (2010), 4 descendants of its own
- K191557: CentriMag Acute Circulatory Support System (2019), 2 descendants of its own
- K110493: Tandemheart Pump (2011), 2 descendants of its own
- K200306: CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit (2020), 1 descendant of its own
- K183623: LifeSPARC Pump, LifeSPARC Controller (2019), 1 descendant of its own

## 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 Levitronix CentriMag Primary Console is 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 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/K083340
Methodology: https://510kreport.com/methodology