# K200306: CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit

- Pathway: 510(k) (Special)
- Applicant: Abbott (Formerly Thoratec Corporation)
- Decided: Mar 6, 2020 after 29 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: 8 generations back to K852698 (1985). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191557: CentriMag Acute Circulatory Support System, Thoratec Corporation (Now Part of Abbott) (2019) Summary page 7.
- K152161: Thoratec CentriMag Return (Arterial) Cannula Kit, Thoratec Corporation (2015) Summary page 7.
- K152190: Thoratec CentriMag Drainage (Venous) Cannula Kit, Thoratec Corporation (2015) Summary page 7.

## Most influential descendants
- K234118: CentriMag™ Acute Circulatory Support System (2024), 0 descendants of its own

## Indications for use
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.) The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours. The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

Source page: https://510kreport.com/device/K200306
Methodology: https://510kreport.com/methodology